Radio frequency surgical system

ABSTRACT

A circuit for generating a radio-frequency signal for a surgical device is disclosed. The circuit has a voltage regulator that supplies direct current (DC) voltage, a first MOSFET, a second MOSFET, and a MOSFET driver. The MOSFET driver receives the DC voltage supplied from the voltage regulator and has a local oscillator. The local oscillator switches the first MOSFET and the second MOSFET on and off at a frequency generated by the local oscillator. The circuit further includes a transformer connected to the first and second MOSFETs, having a center tap and a main voltage applied at the center tap, and providing an alternating current (AC) output.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application:

-   -   is a divisional of U.S. patent application Ser. No. 14/180,726,        filed on Feb. 14, 2014, now U.S. Pat. No. 9,782,217, which:    -   claims priority to U.S. Provisional Application Ser. No.        61/792,859, filed on Mar. 15, 2013;    -   is a continuation-in-part of U.S. patent application Ser. No.        12/270,111, filed Nov. 13, 2008, now U.S. Pat. No. 9,050,098,        (which claims the priority, under 35 U.S.C. § 119, of U.S.        Provisional Patent Application Ser. Nos. 60/990,784 filed Nov.        28, 2007, 61/030,748 filed Feb. 22, 2008, 61/037,788 filed Mar.        19, 2008, and 61/101,005 filed Sep. 29, 2008);    -   is a continuation-in-part of U.S. patent application Ser. No.        12/324,873, filed Nov. 27, 2008, now U.S. Pat. No. 8,758,342,        (which claims the priority, under 35 U.S.C. § 119, of U.S.        Provisional Patent Application Ser. Nos. 60/990,784 filed Nov.        28, 2007, 61/030,748 filed Feb. 22, 2008, 61/037,788 filed Mar.        19, 2008, and 61/101,005 filed Sep. 29, 2008);    -   is related to U.S. patent application Ser. No. 12/403,710, filed        Mar. 13, 2009, now U.S. Pat. No. 8,491,581 (which claims the        priority, under 35 U.S.C. § 119, of U.S. Provisional Patent        Application Ser. Nos. 61/037,788 filed Mar. 19, 2008, and        61/101,005 filed Sep. 29, 2008);    -   is related to U.S. patent application Ser. No. 12/403,785, filed        Mar. 13, 2009, now U.S. Pat. No. 8,377,059 (which claims the        priority, under 35 U.S.C. § 119, of U.S. Provisional Patent        Application Ser. Nos. 61/037,788 filed Mar. 19, 2008, and        61/101,005 filed Sep. 29, 2008);    -   is related to U.S. patent application Ser. No. 12/403,835, filed        Mar. 13, 2009, now U.S. Pat. No. 8,328,802 (which claims the        priority, under 35 U.S.C. § 119, of U.S. Provisional Patent        Application Ser. Nos. 61/037,788 filed Mar. 19, 2008, and        61/101,005 filed Sep. 29, 2008); and    -   is a continuation-in-part of U.S. patent application Ser. No.        13/397,484, filed Feb. 15, 2012, now U.S. Pat. No. 9,532,829,

the entire disclosures of which are all hereby incorporated herein byreference in their entireties.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

n/a

FIELD OF THE INVENTION

The present invention lies in the field of medical cauterization andcutting devices. The present disclosure relates to a cordlesselectrosurgical forceps for sealing and/or cutting tissue.

BACKGROUND OF THE INVENTION

Electrosurgical forceps utilize both mechanical clamping action andelectrical energy to effect hemostasis by heating the tissue and bloodvessels to coagulate, cauterize and/or seal tissue. As an alternative toopen forceps for use with open surgical procedures, many modern surgeonsuse endoscopes, laparoscopes, and endoscopic/laparoscopic instrumentsfor remotely accessing organs through body orifices or smaller,puncture-like incisions. As a direct result thereof, patients tend tobenefit from less scarring and reduced healing time.

Laparoscopic instruments are inserted into the patient through acannula, or port, which has been made with a trocar. Typical sizes forcannulas range from three millimeters to twelve millimeters. Smallercannulas are usually preferred, which, as can be appreciated, ultimatelypresents a design challenge to instrument manufacturers who must findways to make laparoscopic instruments that fit through the smallercannulas.

Many surgical procedures require cutting or ligating blood vessels orvascular tissue. Due to the inherent spatial considerations of thesurgical cavity, surgeons often have difficulty suturing vessels orperforming other traditional methods of controlling bleeding, e.g.,clamping and/or tying-off transected blood vessels. By utilizing anelectrosurgical forceps, a surgeon can cauterize, coagulate/desiccate,and/or simply reduce or slow bleeding simply by controlling theintensity, frequency, and duration of the electrosurgical energy appliedthrough the jaw members to the tissue. Most small blood vessels, i.e.,in the range below two millimeters in diameter, can often be closedusing standard electrosurgical instruments and techniques. However, if alarger vessel is ligated, it may be necessary for the surgeon to convertthe endoscopic procedure into an open-surgical procedure and therebyabandon the benefits of endoscopic surgery. Alternatively, the surgeoncan seal the larger vessel or tissue.

It is thought that the process of coagulating vessels is fundamentallydifferent from electrosurgical vessel sealing. For the purposes herein,“coagulation” is defined as a process of desiccating tissue wherein thetissue cells are ruptured and dried. “Vessel sealing” or “tissuesealing” is defined as the process of liquefying the collagen in thetissue so that it reforms into a fused mass. Coagulation of smallvessels is sufficient to close them permanently, while larger vesselsneed to be sealed to assure permanent closure.

To seal larger vessels (or tissue) effectively two predominantmechanical parameters must be accurately controlled—the pressure appliedto the vessel (tissue) and the gap distance between the electrodes—bothof which are affected by the thickness of the sealed vessel (which termalso refers to tissue when used hereinafter and vice versa). Moreparticularly, accurate application of pressure is important to opposethe walls of the vessel, to reduce the tissue impedance to a low enoughvalue that allows enough electrosurgical energy through the tissue, toovercome the forces of expansion during tissue heating, and tocontribute to the end tissue thickness, which is an indication of a goodseal. It has been determined that a typical fused vessel wall is optimumbetween 0.001 and 0.006 inches. Below this range, the seal may shred ortear and, above this range, the lumens may not be sealed properly oreffectively.

With respect to effective sealing of smaller vessels, the pressureapplied to the tissue tends to become less relevant, whereas the gapdistance between the electrically conductive surfaces becomes moresignificant. In other words, the chances of the two electricallyconductive surfaces touching during activation increases as vesselsbecome smaller.

Many known instruments include blade members or shearing members thatsimply cut tissue in a mechanical and/or electromechanical manner andare relatively ineffective for vessel sealing purposes. Otherinstruments rely on clamping pressure alone to procure proper sealingthickness and are not designed to take into account gap tolerancesand/or parallelism and flatness requirements, which are parameters that,if properly controlled, can assure a consistent and effective tissueseal. For example, it is known that it is difficult to adequatelycontrol thickness of the resulting sealed tissue by controlling clampingpressure alone for either of two reasons: 1) if too much force isapplied, there is a possibility that the two poles will touch and energywill not be transferred through the tissue resulting in an ineffectiveseal; or 2) if too low a force is applied, the tissue may prematurelymove prior to activation and sealing and/or a thicker, less reliableseal may be created.

As mentioned above, to seal larger vessels or tissue properly andeffectively, a greater closure force between opposing jaw members isrequired. It is known that a large closure force between the jawstypically requires a large moment about the pivot for each jaw. Thispresents a design challenge because the jaw members are typicallyaffixed with pins that are positioned to have small moment arms withrespect to the pivot of each jaw member. A large force, coupled with asmall moment arm, is undesirable because the large forces may shear thepivot pins. As a result, designers must compensate for these largeclosure forces by either designing instruments with metal pins and/or bydesigning instruments that at least partially offload these closureforces to reduce the chances of mechanical failure. As can beappreciated, if metal pivot pins are employed, the metal pins must beinsulated to avoid the pin acting as an alternate current path betweenthe jaw members, which may prove detrimental to effective sealing.

Increasing the closure forces between electrodes may have otherundesirable effects, e.g., it may cause the opposing electrodes to comeinto close contact with one another, which may result in a shortcircuit, and a small closure force may cause premature movement of thetissue during compression and prior to activation. As a result thereof,providing an instrument that consistently provides the appropriateclosure force between opposing electrode within a preferred pressurerange will enhance the chances of a successful seal. As can beappreciated, relying on a surgeon to manually provide the appropriateclosure force within the appropriate range on a consistent basis wouldbe difficult and the resultant effectiveness and quality of the seal mayvary. Moreover, the overall success of creating an effective tissue sealis greatly reliant upon the user's expertise, vision, dexterity, andexperience in judging the appropriate closure force to seal the vesseluniformly, consistently, and effectively. In other words, the success ofthe seal would greatly depend upon the ultimate skill of the surgeonrather than the efficiency of the instrument.

The number of operations needed to uniformly, consistently, andeffectively seal the vessel or tissue with such a device influences theprocedure, for example, by increasingly relying on the skill of thesurgeon. Typical actuation assemblies require the surgeon to perform atleast four steps. With the device jaws in the normally open position,the surgeon closes the jaws by actuating a main lever. This lever canhave a “ball-point pen” actuation, in that it is a push-to-lock andpush-again-to-unlock (or pull-to-lock and pull-again-to-unlock) or itcan just be a pull and release lever. With the main lever motion, thejaws close and impart the sealing force to the tissue or vessel. Thesurgeon, in a second step, presses a button to actuate theelectrocautery (signal) and seal the tissue. With appropriate electronicmeasurements or indicators, the device informs the surgeon when sealingis complete. In a third step, the surgeon pulls a cutting trigger, whichphysically moves a blade distally to cut the sealed tissue. If thetrigger is open-biased (for example, with a spring), it can retract theblade automatically from the tissue when released. If the blade does notstick in the tissue and does retract, the surgeon is required, in afourth step, to unlock the main lever by pulling it, again, and lettingit spring back to its original, open position through the force of alarger bias, such as another spring, or merely lets it return to theoriginal un-actuated position. If the blade sticks in the extendedposition, which would prevent the jaws from opening thereafter, a safetydevice can exist to retract the blade and insure that the jaws can beopened after the surgical procedure is carried out.

It has been found that the pressure range for assuring a consistent andeffective seal is between about 3 kg/cm² to about 16 kg/cm² and,preferably, within a working range of 7 kg/cm² to 13 kg/cm².Manufacturing an instrument that is capable of providing a closurepressure within this working range has been shown to be effective forsealing arteries, tissues, and other vascular bundles.

Various force-actuating assemblies have been developed in the past forproviding the appropriate closure forces to effect vessel sealing. Forexample, one such actuating assembly has been developed by ValleylabInc., a division of Tyco Healthcare LP, for use with Valleylab's vesselsealing and dividing instrument commonly sold under the registeredtrademark LIGASURE ATLAS®. This assembly includes a four-bar mechanicallinkage, a spring, and a drive assembly that cooperate to consistentlyprovide and maintain tissue pressures within the above working ranges.The LIGASURE ATLAS® is designed to fit through a 10 mm cannula andincludes a bi-lateral jaw closure mechanism that is activated by a footswitch. A trigger assembly extends a knife distally to separate thetissue along the tissue seal. A rotating mechanism is associated withdistal end of the handle to allow a surgeon to rotate the jaw membersselectively to facilitate grasping tissue. Descriptions of such systemsand various methods relating thereto can be found in U.S. Pat. Nos.7,083,618, 7,101,371, and 7,150,749. The contents of all of theseapplications are hereby incorporated by reference herein.

All of the prior art RF vessel sealing devices require a table-toppower-and-signal supply box connected to the electrodes of the jawsthrough a cumbersome power-and-signal supply line. The supply box takesup precious room within an operating suite. In addition, the supply boxis expensive to produce, requiring the surgeon/hospital to expendsignificant amounts of capital to keep the unit on hand. Additionally,the supply line adds cost to produce and maintain. Importantly, thesupply line commonly interferes with the surgeon's full freedom ofmovement during use.

It would be desirable to eliminate the need for large tabletop powersupplies and controllers. In particular, it would be desirable todevelop a vessel-sealing instrument that is entirely independent of thetabletop power-and-signal supply box and the supply line. It would bealso desirable to miniaturize the power supply and controllers for thesealing instrument.

SUMMARY OF THE INVENTION

The device according to an exemplary embodiment of the invention is asurgical bipolar cauterization and cutting device (possiblypower-assisted) that can be used, in particular, to seal and cut tissuewhen desired. In an embodiment of the device, measures for carrying outboth the cauterization and cutting functions can be entirely containedwithin the device. The invention overcomes the above-noted and otherdeficiencies of the prior art by providing a smaller, simplervessel-sealing instrument where power is supplied by one or morebatteries. The invention entirely eliminates the need for large tabletoppower supplies and controllers by miniaturizing the power supply andcontrollers for the sealing instrument. This miniaturization occurs invarious embodiments and includes, in particular, a hand-held sealinginstrument having no power or control cords; it is self-powered and allcontrol circuitry and power supplies reside in the handle of instrument.The inventive instrument provides various configurations for locatingthe control and power-supply circuitry, some of which allow thecircuitry to be entirely removed from the device and modularly exchangedwith other circuitry. Significantly, the instrument of the inventionimproves upon the sealing end effector by incorporating a passivelyarticulating end effector. Accordingly, sealing is easier to affect andbecomes more reliable due to the customized placement now made possible.

The power-assisted actuation assembly of the present invention reducesthe number of steps to effect the surgical procedure and, while doingso, provides additional benefits. With the jaws of the inventive devicein the normally open position, the surgeon closes the jaws by actuatinga main lever. Like the prior art, this lever can have the pull-to-lockand pull-again-to-unlock actuation assembly. With this first pullingmotion, the jaws close and impart a first intermediate sealing force tothe tissue or vessel. This force is not the final compressive force butis merely an intermediate stage that securely holds the tissuetherebetween. Thereafter, in a second step, the surgeon merely presses asingle button on the device and the entire procedure is carried outautomatically—the procedure including, for example, a determination ofOptimal Tissue Compression (OTC), an electrocautery process to causesealing of the tissue, a cutting movement through the sealed tissue, anda release of the jaws back to the intermediate stage. The process isfinalized in the third step by a second pulling motion on the main leverto open the jaws fully. It is noted that, in another exemplaryembodiment of the invention, the electronic control assembly can beconfigured to automatically actuate the main lever and, thereby, openthe jaws for release of the sealed/cut tissue, making it ready for thenext sealing/cutting procedure. With the invention, therefore, thesurgeon can effect a sealing and cutting procedure with only two orthree steps, these steps not requiring the surgeon to provide anysignificant external force (such as physically moving a trigger) otherthan initiating the first closure of the main lever.

As set forth in the preceding paragraph, the device of the instantinvention is able to automatically compress the tissue at a pre-definedforce that allows beneficial healing without irretrievably harming thecompressed tissue. It is known that, when tissue is being compressed(whether a single layer or multiple layers) and before cutting thetissue, it is desirable for the tissue to be at a certain compressivestate (OTC) so that a desirous medical change can occur; at the sametime, the tissue should not be compressed too far to cause tissuenecrosis. Because there is no way to precisely control the exact kind oftissue that is being placed within the compressing jaws, it is notpossible to ensure that the tissue is compressed within an OptimalTissue Compression range, referred to as an OTC range. Therefore, rulingout of tissue necrosis is difficult or not possible for prior artelectrocautery devices.

The OTC range of tissue is a compression range in which liquid isremoved from the tissue (i.e., desiccates the tissue) without damagingor necrosing the tissue. As the liquid from the tissue exits the tissuehowever (due to compression exerted upon the tissue by the jaws), thecompressive force that is being imposed upon the tissue naturallyreduces—because the jaws are “locked” in position and less mass ispresent between the opposing jaws due to the desiccation. In someinstances, this reduction can allow the imparted tissue compression toexit the OTC range. The device of the invention includes an OTCdetection device that provides feedback actively to the motorized jawscompressing the tissue. This self-adjusting compression device keepscompression force on the interposed tissue within the OTC compressionrange even after being desiccated. More specifically, after the mainlever is compressed and the automatic control switch is actuated, thedevice of the invention begins monitoring characteristics of either thejaws or the tissue or both to determine whether or not the tissue iscompressed within the OTC range. When in that range, the deviceautomatically starts the sealing and cutting procedure.

In one exemplary embodiment, as the jaw control lever is actuated, aforce switch axially present in the jaw actuation mechanism determinesif the force supplied to the tissue between the jaws is sufficient fordesirable sealing and cutting. If not, then electronics of the switchprevent energy from being supplied to the end effector. Alternatively,the force switch can be used to determine if the force supplied to thetissue between the jaws is insufficient for desirable sealing andcutting. If so, then electronics of the switch prevent energy from beingsupplied to the end effector. Such an exemplary force switch can befound in U.S. Patent Publication No. US20070267281 and is incorporatedherein by reference in its entirety. This force switch can be applied toany of the end effector embodiments described herein.

In an exemplary embodiment, the device/force switch can be configured toindicate to the surgeon (audibly, visually, or tactilely) that thetissue that is about to be sealed and cut is within a desirable OTCrange. A delay can be pre-programmed in the indicator device to give thesurgeon time to abort, if desired, before the surgeon applies energy forsealing and cutting. If the surgeon does not abort the procedure,electrocautery begins and the tissue is sealed. Without any furtheractivation or movement by the surgeon, the device shifts the motorizedblade distally to cut the already sealed tissue. When the blade arrivesat a distal end of the cutting stroke, the device causes the blade toretract automatically from the tissue without any further actuation bythe surgeon. In an exemplary embodiment, appropriately positioned limitswitches can be used to activate the retraction. Powered retractionensures that the blade does not stick in the tissue and that it retractsevery time. At this point, the procedure is completed and, ifappropriate motorized assemblies are included, the device can thenautomatically unlock the main lever, allowing it to spring back to itsoriginal open position (for example, through the force of a biasdevice). Thus, there is no need to include the redundant prior artsafety device between the main lever and the trigger to retract theblade and insure that the jaws can be opened after the surgicalprocedure is carried out.

Consequently, the invention overcomes the above-noted and otherdeficiencies of the prior art by reducing the number of steps that thesurgeon needs to undertake to effect tissue sealing and cutting.Simultaneously, the invention substantially decreases the amount ofphysical force needed heretofore needed to carry out such an operation.By relieving the surgeon of having to force the jaws closed and/or toextend and retract the blade, the surgeon has more physical energy tocomplete the overall surgical procedure, which can be many hours inlength or which must be repeated for many different patients over thecourse of a day.

The invention overcomes the above-noted and other deficiencies of theprior art by entirely eliminating the need for large tabletop powersupplies and controllers and does this by miniaturizing the power supplyand controllers for the sealing instrument. This miniaturization occursin various embodiments and includes, in particular, an entirelyhand-held sealing instrument having no power or control cords. Thus, allcontrol circuitry and power supplies reside inside the handle of theinstrument. In another embodiment, the power supply is self-containedbut located at a distance from the instrument. In yet anotherembodiment, the power supply and the control electronics are located ata distance from the instrument.

Generally, endoscopic surgical control handles include a long shaftbetween an end effector and a handle portion manipulated by the surgeon.This long shaft enables insertion to a desired depth and rotation aboutthe longitudinal axis of the shaft, thereby positioning the end effectorto a degree. With judicious placement of the trocar and use of graspers,for instance, through another trocar, often this amount of positioningis sufficient. It is understood, however, that positioning of the endeffector is constrained by the trocar. Thus, depending upon the natureof the operation to be carried out, it may be desirable to haveadjustment in the positioning of the end effector in addition to thelimited functional movements of insertion and rotation. In particular,it would be desirable to orient the end effector at an axis transverseto the longitudinal axis of the shaft of the instrument. While prior artnon-articulating sealing instruments have great utility and may besuccessfully in many surgical procedures, they are limited to insertionand rotation movements. The present invention enhances such operationwith the ability to move the end effector obliquely. In particular, theinvention overcomes the above-noted and other deficiencies of the priorart by providing a passively articulating end effector to the sealinginstrument.

As used in the art and as used herein, transverse movement of a medicalend effector relative to an instrument shaft is referred toconventionally as “articulation.” Articulated positioning permits thesurgeon to more easily engage tissue in some instances. In prior artmedical devices including control of articulation, the articulationmovement is directed actively from the device handle. This activecontrol can be mechanical and/or electrical. For example, some prior artdevices have levers at the top of the control handle and, when pivotedleft, the end effector articulates left and, when pivoted right, the endeffector articulates right. Some operate with opposite movement. Toeffect such active articulation, it is very difficult for the operatorto use only one hand. Thus, often, the operator must hold the handlewith one hand and pivot the articulation lever with the other hand. Asis known, the trend for laparoscopic and other similar medical devicesis to make them operable with a single hand—this is because surgeonsusing two devices, one in each hand, often lose control of the secondhand when it is necessary to remove their hand from that second deviceto operate an articulation lever of the first device. Loss of devicecontrol is undesirable and extends the surgical procedure if a devicefalls outside the view of the operating surgeon. One prior art deviceuses electrical measures to actively control articulation. In U.S. Pat.No. 7,213,736 to Wales et al., the disclosure argues that electricalpower is supplied to an electrically actuated polymer to articulate theend effector actively in the desired direction. The device in U.S. Pat.No. 7,328,828 to Ortiz et al., requires the surgeon to controlarticulation by hand (see reference numeral 18). Such exemplary priorart devices can be characterized by referring to them as “activearticulation” devices, in which an articulation control device ispresent on the handle and extends through the articulation joint toforce the articulation in either articulation direction. In other words,the forces required to perform articulation are generated internally inthe device.

The invention, in contrast, includes a passive articulation joint thatpermits the surgeon to orient the end effector along an axis transverseto the longitudinal axis of the shaft of the instrument without activearticulation.

The articulation assembly of the present invention has no mechanicalcontrol device in the handle to effect direct control of articulatingmovement of the end effector. There is also no articulation controldevice present at the handle that extends through the articulation jointto force the end effector to articulate in a direction. Instead,articulation of the end effector is dependent upon pressure between asurface of the environment in which the end effector exists and anexterior surface of the end effector, for example, at a location distalof the articulation joint. A torque to pivot the inventive end effectorabout the articulation axis arises from forces external to the device.One force is present by the user holding the handle. The other forceacts distal of the articulation joint and is imparted by the environmentin which the end effector is present and against which the end effectoris being held. In other words, the forces required to performarticulation are external to the device. This motion can be and isreferred to herein as “passive articulation” and the “articulationjoint” of the present invention operates with passive articulation—itrequires a torque external to the device to articulate the end effectorabout the axis of the passive articulation joint.

Articulating surgical instruments generally use one or more firing barsthat move longitudinally within the instrument shaft and through thearticulation joint to carry out a function of the end effector. Onecommon problem with these surgical instruments is control of the firingbar through the articulation joint. At the articulation joint, the endeffector is longitudinally spaced away from the shaft so that the edgesof the shaft and end effector do not collide during articulation. Thisgap must be filled with support material or structure to prevent thefiring bar from buckling out of the joint when the single or multiplefiring bars is subjected to longitudinal firing loads. What is needed isa support structure that guides and supports the single or multiplefiring bars through the articulation joint and bends or curves as theend effector is articulated.

U.S. Pat. No. 5,673,840 to Schulze et al. describes a flexiblearticulation joint that is formed from an elastomeric or plasticmaterial that bends at the flexible joint or “flex neck”. The firingbars are supported and guided through a hollow tube within the flexneck. The flex neck is a portion of the jaw closure mechanism and moveslongitudinally relative to the end effector, shaft, and firing bars whenthe jaws are closed on tissue. The firing bars then move longitudinallywithin the flex neck as the staples are fired and tissue is cut.

U.S. Pat. No. 5,797,537 to Oberlin et al. (assigned to Richard-AllanMedical Industries, Inc.) describes an articulation joint that pivotsaround a pin, rather than bends around a flex joint. In this instrument,firing bars are supported between a pair of spaced support platesconnected at one end to the shaft and at another end to the endeffector. At least one of those connections is a slidable connection.The support plates extend through the articulation joint adjacent to theflexible drive member in the plane of articulation such that the supportplates bend through the gap in the plane of articulation and theflexible firing bar bends against the support when the tip isarticulated in one direction from its aligned position. U.S. Pat. No.6,330,965 to Milliman et al. from U.S. Surgical teaches the use ofsupport plates that are fixedly attached to the shaft and slidablyattached to the end effector.

Although these known support plates guide a firing bar through anarticulation joint, it is believed that performance may be enhanced. Forinstance, it is often desirable for the firing bar to be acceleratedrapidly during firing to ensure sufficient momentum for severing tissueeffectively. Rigidly attached support plates may tend to dislodge inresponse, allowing the firing bar to blow out from the articulationjoint. As a further example, it is desirable for the instrument tooperate in the same manner whether articulated or not. Increasedfriction when articulated would be inconvenient and distracting to theclinician if required to exert a varying amount of firing force.Consequently, the present invention provides an improved articulationmechanism for the surgical instrument that enhances support to thefiring bar through the articulation joint.

In one aspect of the invention, the surgical instrument has a handleportion that releases a lock to allow articulation of the end effectorand to permit cutting while articulated. The articulating-release andcutting mechanisms are transferred through a shaft to the articulationmechanism. The articulation mechanism responds to forces that the userimparts to the end effector and allows articulation of the end effectorout of line with the longitudinal axis of the shaft. The cuttingmechanism responds to the cutting motion and is coupled for movementthrough the articulation mechanism and the end effector. A cuttersupport device allows the cutting mechanism to be supported and keep itin place as articulation occurs.

The movable distal end effector can be center-biased in an advantageousembodiment. This means that, after the distal end is passively movedinto a new articulation position (by engaging the end effector with afeature of the environment, such as surrounding tissue), the nextactuation of the articulation lock release will permit the end effectorto return to a center position under the urging of a center-biasingdevice (if the end effector is free from contact with the environment).In one embodiment, the biasing device is at least one biasing spring andcan be, for example, two biasing springs imparting a biasing force inopposing and, therefore, centering directions. Alternatively, thecenter-biasing device can be a set of spring-loaded plungers disposed oneither side of the end effector at the clevis to urge the end effectorindependently towards the center position. These embodiments areexplained in detail in U.S. Pat. Nos. 7,404,508 and 7,491,080 to Smithet al., which are hereby incorporated by reference herein in theirentireties.

In one exemplary embodiment, the trigger that permits/inhibits passivemovement is in a normally locked position. This lock is released bypulling in the trigger. Once the distal end effector is in a desiredposition, the user releases the trigger, thereby locking the distal endeffector in its new position.

The device according to an exemplary embodiment of the invention is asurgical bipolar cauterization and cutting device that can be used, inparticular, to seal and cut tissue when desired. In one embodiment ofthe device, measures for carrying out both the cauterization and cuttingfunctions can be entirely contained within the device.

Actuation of the device is accomplished using at least one servo in anexemplary embodiment.

The device may also be actuated by multiple electric motors, byhydraulics or pneumatics, or by the transmission of energy through aflexible drive shaft in any way such that the actuation assembly can becontained primarily or entirely in the distal portion of the device.

The work accomplished by any of these measures can be converted intodesirable motions through any single or combination of screw drive, geardrive, wedge, toggle, cam, belt, pulley, cable, bearing, or the likepush rod. In particular, a screw drive is used to transmit the work ofthe electric motor into linear motion. In one embodiment, the motor forthe screw drive resides in the handle. A flexible rotating cable isconnected from the motor to a threaded shaft. Thus, when the motor turnsin either direction, the rotation of the flexible cable is transmittedto the threaded drive shaft and, because the stapling actuator andcutting slide is disposed on the drive shaft, both functions are carriedout by distal movement of the slide. In a second embodiment, the motorresides entirely in the end effector and has a shaft connected to theslide drive shaft, either directly or through transmission gears. Insuch a case, all that is needed in the handle is the on/off and driveshaft direction actuators, the former for turning the motor on and offand the latter determining which direction the motor will spin.

In one aspect of the invention, the instrument actuates an end effectorwith a longitudinally translating firing mechanism that is supportedadvantageously through an articulation mechanism by either flankingsupport plates or a rigid support channel. In the former embodiment, tobetter respond to firing loads on the firing mechanism, one or more endsof each support plate are resiliently or springedly engaged to one sideof the articulation mechanism, and thus are better able to avoidbuckling of the firing mechanism. For example, the pair of supportplates flanks the firing mechanism across the articulation mechanism,each support plate including an end springedly engaged to a frame recessformed in the articulation mechanism to assist in preventing buckling ofthe firing mechanism within or out of the articulation mechanism. In thechannel embodiment, the channel floats in the articulation mechanism andhas surfaces that support either side of the firing mechanism asarticulation occurs in either direction and, thus, avoid buckling of thefiring mechanism. The channel has a floor and two sides. The supportchannel rests freely in a cavity inside the articulation mechanism. Endsof the channel are curved to match curves of the cavity. The supportchannel has various internal surfaces to contact and support the firingmechanism as it is bent within the articulation mechanism and, thereby,assists in preventing buckling of the firing mechanism within or out ofthe articulation mechanism.

With the foregoing and other objects in view, there is provided, inaccordance with the invention, a circuit for generating aradio-frequency signal for a surgical device. The circuit has a voltageregulator that supplies direct current (DC) voltage, a first MOSFET, asecond MOSFET, and a MOSFET driver. The MOSFET driver receives the DCvoltage supplied from the voltage regulator and has a local oscillator.The local oscillator switches the first MOSFET and the second MOSFET onand off at a frequency generated by the local oscillator. The circuitfurther includes a transformer connected to the first and secondMOSFETs, having a center tap and a main voltage applied at the centertap, and providing an alternating current (AC) output.

In accordance with a further feature of the invention, there is providedan interlock terminal that controls power to the circuit through thevoltage regulator.

In accordance with an added feature of the invention, the voltageregulator supplies DC voltage to the local oscillator and to the MOSFETdriver.

In accordance with an additional feature of the invention, the MOSFETdriver is self-oscillating.

In accordance with yet another feature of the invention, the MOSFETdriver is a dual MOSFET driver.

In accordance with yet a further feature of the invention, the MOSFETdriver establishes the frequency of the local oscillator.

In accordance with yet an added feature of the invention, there isprovided a capacitor and a resistor connected to the local oscillatorand having respective capacitance and resistance values that set thefrequency of the local oscillator.

In accordance with yet an additional feature of the invention, theMOSFET driver has a resistance for time delay port connected to theresistor.

In accordance with again another feature of the invention, the MOSFETdriver has an oscillator timing capacitor port connected to thecapacitor.

In accordance with again a further feature of the invention, thefrequency is set to approximately 300 kHz.

In accordance with again an added feature of the invention, thetransformer has a first input grounded by the first MOSFET.

In accordance with again an additional feature of the invention, thetransformer has a second input grounded by the second MOSFET.

In accordance with still another feature of the invention, the output ofthe transformer is a product of a turns ratio of the transformer and thevoltage supplied by the voltage regulator.

In accordance with still a further feature of the invention, thetransformer has a secondary side and the output of the transformer is atthe secondary side and comprises an output voltage.

In accordance with still an added feature of the invention, the outputvoltage on the secondary side of the transformer has a frequency ofapproximately 300 kHz.

With the objects of the invention in view, there is also provided acircuit for generating a radio-frequency signal for a surgical device.The circuit has a voltage regulator supplying direct current (DC)voltage, a first MOSFET, a second MOSFET, and a self-oscillating dualMOSFET driver. The self-oscillating dual MOSFET driver receives the DCvoltage supplied from the voltage regulator and has a local oscillator.The local oscillator switches the first MOSFET and the second MOSFET onand off at a frequency generated by the local oscillator. The circuitfurther includes a transformer having a center tap and a main voltageapplied at the center tap, a first input grounded by the first MOSFET,and a second input grounded by the second MOSFET, and providing analternating current (AC) output.

In accordance with a further feature of the invention, the MOSFET driverestablishes the frequency of the local oscillator.

In accordance with an added feature of the invention, there is provideda capacitor and a resistor connected to the local oscillator and havingrespective capacitance and resistance values that set the frequency ofthe local oscillator.

In accordance with an additional feature of the invention, the MOSFETdriver has a resistance for time delay port connected to the resistorand the MOSFET driver has an oscillator timing capacitor port connectedto the capacitor.

In accordance with a concomitant feature of the invention, thetransformer has a secondary side and the output of the transformer is atthe secondary side and comprises an output voltage having a frequency ofapproximately 300 kHz.

The invention overcomes the above-noted and other deficiencies of theprior art by improving wear resistance and lubricity of the working endof the sealing instrument by utilizing hard-coat anodizing at selectedlocations on the working area of the instrument.

In still a further aspect of the invention, a surgical instrument has ahandle portion that includes a jaw closing device, a blade-firingdevice, and an articulation unlocking device, each operable through ashaft at the end of which is the end effector. The end effectorincludes, in one exemplary embodiment, a jaw fixedly coupled to theshaft and an anvil pivotally coupled to the shaft and controlled by thejaw closing device. Of course, both jaws can be pivotable, whetherco-dependently or independently. The blade-firing device is connectedfrom the handle to the end effector through the shaft and through thearticulation mechanism or joint (when such joint is present). Theblade-firing device carries out the cutting when actuated. Thearticulation mechanism allows movement of the end effector with respectto the shaft. The articulation mechanism is distally coupled to theshaft and permits passive articulation (also referred to as naturalarticulation) of the end effector after the articulation unlockingdevice is actuated (i.e., unlocked). With such actuation, the endeffector is free to articulate in response to a force(s) that acts uponthe end effector. In other words, when the articulation lock isunlocked, pressure of the environment against the end effector willcause articulation of the end effector with respect to the shaft.

With the foregoing and other objects in view, there is provided, inaccordance with the invention, a surgical device including aradio-frequency-signal-generation assembly including aradio-frequency-signal-generation circuit operable to generate aradio-frequency signal at an output and adapted to couple to aswitch-mode power supply; and a surgical handle including an endeffector having at least one jaw with at least one electrical contact,the end effector including at least one signal input that electricallyconnects to the output to provide the radio-frequency signal at the atleast one electrical contact.

The radio-frequency generation circuit is small, inexpensive, and thesimplest radio-frequency unit for vessel sealing. The radio-frequencycircuit uses a novel push/pull outlet with a center tap. In contrast,most prior art devices are regulated by pulse width modulation on theoutput. Also disclosed is a novel method created for the switch modepower supply that allows the device to provide better tissue sealing.

Endoscopic and laparoscopic surgery requires the physician to be able touse both hands independently. Prior art devices, with their activearticulation controls, require both hands for using the single device.The prior art devices, therefore, make such surgeries extremelydifficult or not possible. A significant advantage of the presentinvention is that the articulation of the end effector is passive andlockable without a need for a second hand. In other words, the endeffector can be unlocked, subsequently moved into a desired articulatedposition, and, then, caused be retained in the new position—all of thisbeing done with a one-handed operation.

A further advantage of the present invention is that the axial movementof the end effector is dynamically rotatable about the longitudinal axisof the device at any time by the user. A rotation device axially fixedlybut rotationally freely connects the handle to the distal componentsincluding the shaft, the articulation mechanism, and the end effector.Rotation of the distal components occurs by applying a rotational forceto the rotation device about the longitudinal axis of the shaft in thedesired direction. In an embodiment where passive articulation ispresent, pulling the rotation device in a direction away from the endeffector unlocks the end effector to permit passive articulation (in anexemplary embodiment, the rotation device is bell-shaped). This rotatingmovement, in combination with the off-axis articulation movement of theend effector creates a compound angle at the distal end of the device toaid in accurate positioning of the end effector.

To support the blade-firing mechanism, a pair of support plates canflank the firing mechanism across the articulation mechanism, eachsupport plate including an end springedly engaged to a frame recessformed in the articulation mechanism, or a rigid channel can surroundthe firing mechanism across the articulation mechanism. Alternatively, aU-shaped or H-shaped rigid channel can be provided for such support (andfor electrically isolating the cutting and jaw-moving controls from oneanother). Thereby, an improved sealing and cutting instrument mayincorporate a blade-firing device that withstands high firing loads yetdoes not introduce significantly increased firing forces whenarticulated.

The device may be manufactured in different lengths and/or bemanufactured in diameters appropriate for either laparoscopic orendoscopic use, or both. A replaceable end-effector cartridge can beused. In addition, the actuation device can be constructed to attach toa distal end of a flexible endoscope.

The Optimal Tissue Compression (OTC) range of tissue is a compressionrange in which liquid is removed from the tissue (i.e., desiccates thetissue) without damaging or necrosing the tissue. In one exemplaryembodiment, as the jaw control lever is actuated, a force switch axiallypresent in the jaw actuation mechanism determines if the force suppliedto the tissue between the jaws is sufficient for desirable sealing andcutting. If not, then electronics of the switch prevent energy frombeing supplied to the end effector. Alternatively, the force switch canbe used to determine if the force supplied to the tissue between thejaws is insufficient for desirable sealing and cutting. If so, thenelectronics of the switch prevent energy from being supplied to the endeffector. Such a force switch can be found in U.S. Patent PublicationNo. US20070267281 and is incorporated herein by reference in itsentirety. In an exemplary embodiment, the force switch can be configuredto indicate to the surgeon (audibly, visually, or tactilely) that thetissue is within a desirable OTC range. A delay can be pre-programmed inthe indicator device to give the surgeon time to abort, if desired,before the surgeon applies energy for sealing and cutting. This forceswitch can be applied to any of the end effector embodiments describedherein.

Other features that are considered as characteristic for the inventionare set forth in the appended claims.

Although the invention is illustrated and described herein as embodiedin a cordless medical cauterization and cutting device, it is,nevertheless, not intended to be limited to the details shown becausevarious modifications and structural changes may be made therein withoutdeparting from the spirit of the invention and within the scope andrange of equivalents of the claims.

The construction and method of operation of the invention, however,together with additional objects and advantages thereof, will be bestunderstood from the following description of specific embodiments whenread in connection with the accompanying drawings.

Other features that are considered as characteristic for the inventionare set forth in the appended claims. As required, detailed embodimentsof the present invention are disclosed herein; however, it is to beunderstood that the disclosed embodiments are merely exemplary of theinvention, which can be embodied in various forms. Therefore, specificstructural and functional details disclosed herein are not to beinterpreted as limiting, but merely as a basis for the claims and as arepresentative basis for teaching one of ordinary skill in the art tovariously employ the present invention in virtually any appropriatelydetailed structure. Further, the terms and phrases used herein are notintended to be limiting; but rather, to provide an understandabledescription of the invention. While the specification concludes withclaims defining the features of the invention that are regarded asnovel, it is believed that the invention will be better understood froma consideration of the following description in conjunction with thedrawing figures, in which like reference numerals are carried forward.The figures of the drawings are not drawn to scale.

Before the present invention is disclosed and described, it is to beunderstood that the terminology used herein is for the purpose ofdescribing particular embodiments only and is not intended to belimiting. The terms “a” or “an”, as used herein, are defined as one ormore than one. The term “plurality,” as used herein, is defined as twoor more than two. The term “another,” as used herein, is defined as atleast a second or more. The terms “including” and/or “having,” as usedherein, are defined as comprising (i.e., open language). The term“coupled,” as used herein, is defined as connected, although notnecessarily directly, and not necessarily mechanically.

As used herein, the term “about” or “approximately” applies to allnumeric values, whether or not explicitly indicated. These termsgenerally refer to a range of numbers that one of skill in the art wouldconsider equivalent to the recited values (i.e., having the samefunction or result). In many instances these terms may include numbersthat are rounded to the nearest significant figure. In this document,the term “longitudinal” should be understood to mean in a directioncorresponding to an elongated direction of the device between the endeffector and the control handle. The terms “program,” “softwareapplication,” and the like as used herein, are defined as a sequence ofinstructions designed for execution on a computer system. A “program,”“computer program,” or “software application” may include a subroutine,a function, a procedure, an object method, an object implementation, anexecutable application, an applet, a servlet, a source code, an objectcode, a shared library/dynamic load library and/or other sequence ofinstructions designed for execution on a computer system.

BRIEF DESCRIPTION OF THE DRAWINGS

Advantages of embodiments of the present invention will be apparent fromthe following detailed description of the preferred embodiments thereof,which description should be considered in conjunction with theaccompanying drawings in which:

FIG. 1 is a fragmentary, perspective and partially cut away view of theend effector of the present invention with the shaft removed and withthe jaws in a closed orientation;

FIG. 2 is a fragmentary, perspective view of the end effector of FIG. 1with one jaw in an open orientation past a max-open position and withthe lower jaw removed;

FIG. 3 is a fragmentary, side elevational view of the end effector ofFIG. 1 with the lower jaw removed and with the upper jaw is an openorientation past the max-open position;

FIG. 4 is a fragmentary, longitudinally cross-sectional view of the endeffector of FIG. 1 in a first longitudinally cross-sectional planeparallel to a plane of the blade;

FIG. 5 is a fragmentary, longitudinally cross-sectional view of the endeffector of FIG. 1 in a third longitudinally cross-sectional planecoplanar with the blade plane;

FIG. 6 is a colored, fragmentary, partially transparent, sideelevational view of the end effector of FIG. 1 with the upper jawremoved and the lower jaw in a closed orientation;

FIG. 7 is a colored, fragmentary, partially transparent, sideelevational view of the end effector of FIG. 1 with the upper jawremoved, the lower jaw in a partially open orientation, and the blade ina retracted position;

FIG. 8 is a colored, fragmentary, partially transparent, sideelevational view of the end effector of FIG. 7 with the blade in anextended position;

FIG. 9 is a colored, fragmentary, partially transparent, sideelevational view of the end effector of FIG. 7 with the lower jaw in anextended open position to restrict movement of the blade body and theblade control device;

FIG. 10 is a fragmentary, transverse cross-sectional view of the endeffector of FIG. 1 in a second transverse cross-sectional planetransverse to the linear extent of the blade and through the blade bodyand the pivot bosses of the jaws;

FIG. 11 is a fragmentary, longitudinally cross-sectional view of the endeffector of FIG. 1 in a third longitudinally cross-sectional planetransverse to the blade plane and through a blade control device;

FIG. 12 is a process flow diagram illustrating the steps for operating aprior art electrocautery sealing and cutting surgical device;

FIG. 13 is a fragmentary perspective view of an exemplary embodiment ofa passive articulating electrocautery sealing and cutting surgicaldevice according to the invention with the jaws in an open orientationpast a max-open position, a blade in a partially extended position, andan articulation joint in an aligned articulation position;

FIG. 14 is a fragmentary perspective and partially transparent view ofthe passive articulating electrocautery sealing and cutting surgicaldevice of FIG. 13 with a distal joint portion removed, an upper proximaljoint portion removed, a transparent lower proximal joint portion, and atransparent outer shaft portion;

FIG. 15 is a fragmentary perspective and partially transparent view ofthe passive articulating electrocautery sealing and cutting surgicaldevice of FIG. 14 with the jaws in a closed orientation and the lowerproximal joint portion removed;

FIG. 16 is a fragmentary enlarged perspective and partially transparentview from above the passive articulating electrocautery sealing andcutting surgical device of FIG. 13 with a transparent articulation jointand a transparent outer shaft portion;

FIG. 17 is a fragmentary elevational and partially transparent view of ajoint of the passive articulating electrocautery sealing and cuttingsurgical device of FIG. 13;

FIG. 18 is a fragmentary elevational and partially transparent side viewof a passive articulating electrocautery sealing and cutting surgicaldevice of with a right side cover of the handle removed and a batteryassembly inserted within the handle;

FIG. 19 is a perspective view of the underside of the passivearticulating electrocautery sealing and cutting surgical device of FIG.18 showing a switch disposed on an underside of the first trigger;

FIG. 20 is a fragmentary elevational side view of the passivearticulating electrocautery sealing and cutting surgical device of FIG.18 with the battery assembly partially inserted within the handle;

FIG. 21 is an enlarged fragmentary elevational side view of the batterycompartment of the handle of FIG. 18 with the right side cover of thehandle removed and a door in an intermediate position partially ejectingthe battery assembly from the battery compartment;

FIG. 22 is a fragmentary perspective and partially transparent view ofthe passive articulating electrocautery sealing and cutting surgicaldevice of FIG. 18;

FIG. 23 is a fragmentary perspective and partially transparent view ofthe passive articulating electrocautery sealing and cutting surgicaldevice of FIG. 18 with both halves of the handle removed and the firsttrigger partially depressed;

FIG. 24 is a fragmentary perspective and partially transparent view ofthe passive articulating electrocautery sealing and cutting surgicaldevice of FIG. 23 with the first trigger fully depressed;

FIG. 25 is a fragmentary elevational and partially transparent view ofthe passive articulating electrocautery sealing and cutting surgicaldevice of FIG. 24 with the first and second triggers depressed;

FIG. 26 is a fragmentary elevational and partially transparent view ofthe passive articulating electrocautery sealing and cutting surgicaldevice of FIG. 25 with the first and second triggers partially releasedfrom the depressed position of FIG. 25;

FIG. 27 is a fragmentary elevational and partially transparent view ofthe passive articulating electrocautery sealing and cutting surgicaldevice of FIG. 26 with the first trigger partially released from thedepressed position of FIG. 26, and the second trigger fully released;

FIG. 28 is an enlarged fragmentary perspective and partially transparentview of the upper portion of the second articulation trigger of thepassive articulating electrocautery sealing and cutting surgical deviceof FIG. 18 with the left and right side covers of the handle removed;

FIG. 29 is a fragmentary enlarged perspective and partially transparentview of the passive articulating electrocautery sealing and cuttingsurgical device of FIGS. 13 to 17 with the jaws open;

FIG. 30 is an elevational side view of an electrocautery sealing andcutting surgical device according to the present invention;

FIG. 31 is a fragmentary elevational side view of the electrocauterysealing and cutting surgical device of FIG. 30 with a left side cover ofthe handle removed and a battery assembly inserted within the handle;

FIG. 32 is a fragmentary elevational side view of the electrocauterysealing and cutting surgical device of FIG. 30 with a left side cover ofthe handle removed and a first trigger depressed;

FIG. 33 is a fragmentary elevational side view of the electrocauterysealing and cutting surgical device of FIG. 30 with a left side cover ofthe handle removed and the battery door opened and automaticallyejecting the battery assembly from the battery chamber;

FIG. 34 is a fragmentary elevational side view of the electrocauterysealing and cutting surgical device of FIG. 30 with a left side cover ofthe handle removed and the battery assembly separated from the handle;

FIG. 35 is a perspective and partially transparent view of the batteryassembly of FIG. 30;

FIG. 36 is a perspective and partially cut-away view of an alternativeembodiment of the inventive battery assembly according to the presentinvention;

FIG. 37 is an exploded perspective view of the battery assembly of FIG.36;

FIG. 38 is a fragmentary elevational side view of an alternativeembodiment of the passive articulating electrocautery sealing andcutting surgical device according to the present invention with a leftside cover of the handle removed and a battery inserted within thehandle;

FIG. 39 is a fragmentary elevational side view of the passivearticulating electrocautery sealing and cutting surgical device of FIG.38 with first and second triggers depressed to a first position;

FIG. 40 is a fragmentary elevational side view of the passivearticulating electrocautery sealing and cutting surgical device of FIG.38 with the first trigger depressed to the first position and the secondtrigger depressed to a second position;

FIG. 41 is a fragmentary elevational side view of the passivearticulating electrocautery sealing and cutting surgical device of FIG.40 with the first trigger depressed to the first position and the secondtrigger depressed to a third position;

FIG. 42 is an elevational side view of the passive articulatingelectrocautery sealing and cutting surgical device of FIG. 38;

FIG. 43 is a fragmentary and partially exploded elevational side view ofthe passive articulating electrocautery sealing and cutting surgicaldevice of FIG. 38 with the left side cover of the handle removed, abattery door opened, and the battery outside a battery chamber;

FIG. 44 is a fragmentary side perspective view of another exemplaryembodiment of a passive articulating electrocautery sealing and cuttingsurgical device according to the present invention with a left sidecover of the handle removed, a battery assembly inserted within thehandle, and a removable, sealed proximal signal generation circuitryassembly;

FIG. 45 is a fragmentary elevational side view and partiallycross-sectional view of the passive articulating electrocautery sealingand cutting surgical device of FIG. 44;

FIG. 46 is a fragmentary side perspective and exploded view of thepassive articulating electrocautery sealing and cutting surgical deviceof FIG. 44 with the left side cover present and with the proximal signalgeneration circuitry assembly in a removed position;

FIG. 47 is a fragmentary enlarged perspective and partially transparentview of another exemplary embodiment of an electrocautery sealing andcutting surgical end effector according to the present invention withserrated jaws in a max-open position;

FIG. 48 is a fragmentary perspective view of the electrocautery sealingand cutting surgical end effector of FIG. 47 with the jaws open past themax-open position;

FIG. 49 is a fragmentary enlarged perspective view from a distal end ofthe electrocautery sealing and cutting surgical end effector of FIG. 48with an outer portion of the upper jaw removed;

FIG. 50 is a fragmentary enlarged perspective view from a proximal sideof the electrocautery sealing and cutting surgical end effector of FIG.47;

FIG. 51 is a fragmentary enlarged perspective view from a distal side ofa passive articulating electrocautery sealing and cutting surgical endeffector according to the present invention with the jaws past amax-open position and with the blade removed;

FIG. 52 is a fragmentary enlarged perspective and partially transparentview from a distal side of the passive articulating electrocauterysealing and cutting surgical end effector of FIG. 51;

FIG. 53 is a fragmentary enlarged perspective and partially transparentview from a distal side of the passive articulating electrocauterysealing and cutting surgical end effector of FIG. 52 with an upper partof a two-part proximal articulation joint portion removed;

FIG. 54 is a fragmentary, side elevational view of an exemplaryembodiment of a powered-blade electrocautery and cutting deviceaccording to the present invention with a right side cover and endeffector removed;

FIG. 55 is a perspective view from above a side of a jaw control slideof the device of FIG. 54;

FIG. 56 is a perspective view from above a side of a blade control slideof the device of FIG. 54;

FIG. 57 is a perspective view from above a side of the jaw and bladecontrol slides of FIGS. 55 and 56;

FIG. 58 is a fragmentary, perspective view of the device of FIG. 54 in ajaw-open and blade-retracted state with a control trigger removed;

FIG. 59 is a fragmentary, perspective view of the device of FIG. 58 in ajaw-closed and blade-retracted state;

FIG. 60 is a fragmentary, perspective view of the device of FIG. 59 in ajaw-closed and blade-extended state;

FIG. 61 is a fragmentary, side elevational view of another exemplaryembodiment of a powered-blade electrocautery and cutting deviceaccording to the present invention

FIG. 62 is a fragmentary, perspective view of the device of FIG. 61 in ajaw-open and blade-retracted state with a control trigger removed;

FIG. 63 is a fragmentary, perspective view of the device of FIG. 62 in ajaw-closed and blade-retracted state;

FIG. 64 is a fragmentary, perspective view of the device of FIG. 63 in ajaw-closed and blade-extended state;

FIG. 65 is a process flow diagram illustrating the steps for operating aprior art electrocautery sealing and cutting surgical device;

FIG. 66 is a process flow diagram illustrating the steps for operatingone exemplary embodiment of an electrocautery sealing and cuttingsurgical device according to the present invention;

FIG. 67 is a process flow diagram illustrating the steps for operatinganother exemplary embodiment of an electrocautery sealing and cuttingsurgical device according to the present invention;

FIG. 68 is a plan view of a first layer of an exemplary embodiment of afour-layer circuit board;

FIG. 69 is a plan view of a second layer of an exemplary embodiment ofthe four-layer circuit board;

FIG. 70 is a plan view of a third layer of an exemplary embodiment ofthe four-layer circuit board;

FIG. 71 is a plan view of a fourth layer of an exemplary embodiment ofthe four-layer circuit board;

FIG. 72 is a circuit diagram of an exemplary embodiment of aradio-frequency generator;

FIG. 73 is a plan view of a first layer of an exemplary embodiment of atwo-layer circuit board;

FIG. 74 is a plan view of a second layer of an exemplary embodiment ofthe two-layer circuit board; and

FIG. 75 is a process flow diagram illustrating steps for operating anexemplary embodiment of a method for providing RF tissue sealing.

DETAILED DESCRIPTION OF THE INVENTION

Aspects of the invention are disclosed in the following description andrelated drawings directed to specific embodiments of the invention.Alternate embodiments may be devised without departing from the spiritor the scope of the invention. Additionally, well-known elements ofexemplary embodiments of the invention will not be described in detailor will be omitted so as not to obscure the relevant details of theinvention.

Before the present invention is disclosed and described, it is to beunderstood that the terminology used herein is for the purpose ofdescribing particular embodiments only and is not intended to belimiting. It must be noted that, as used in the specification and theappended claims, the singular forms “a,” “an,” and “the” include pluralreferences unless the context clearly dictates otherwise.

While the specification concludes with claims defining the features ofthe invention that are regarded as novel, it is believed that theinvention will be better understood from a consideration of thefollowing description in conjunction with the drawing figures, in whichlike reference numerals are carried forward. The figures of the drawingsare not drawn to scale.

Referring now to the figures of the drawings in detail and first,particularly to FIG. 1 thereof, there is shown an exemplary embodimentof a bipolar cautery and cutting end effector 100 of the presentinvention. In many of the figures of the drawings, the proximal portionof the device (e.g., the handle) is not shown or is illustrated onlydiagrammatically, for example, the exemplary embodiment shown in FIGS. 1to 11. In the figures, a cutting actuation wire 10 extends a distanceproximally to a non-illustrated cutting actuation assembly that iscapable of moving the cutting actuation wire 10 in the longitudinaldirection (L). Similarly, a pair of jaw actuation wires 20, 30 extendsproximally towards the non-illustrated jaw actuation assembly, which iscapable of moving the jaw actuation wires 20, 30 in the longitudinaldirection (L). The wires 20, 30 can extend all of the way back to theactuation assembly and can be individually actuatable or separatelyactuatable. Alternatively, the wires 20, 30 can meet at an intermediatepoint and, thereafter, a single actuator can extend proximally back tothe actuation assembly.

The bipolar cautery and cutting end effector 100 of this embodiment ofthe present invention is shown only to its proximal end in thesefigures. Between this proximal end and the non-illustrated actuationassembly is an outer sheath 40 (illustrated only diagrammatically bydashed lines) having an outer shape that is substantially similar oridentical to an outer shape of the clevis 110 or that transitions from afirst shape smoothly to the outer shape of the clevis 110. For example,in a flexible embodiment of the outer sheath 40, the outer sheath 40 canbe comprised of a flexible inner coil (e.g., of stainless steel) with anouter coating of a polymer that is, for example, heat-shrunken upon thecoil. In a non-flexible exemplary embodiment of the outer sheath 40, thesheath 40 can be a one-piece tube-shaped cannula of stainless steel.Other similar embodiments for flexible and non-flexible end effectorextensions are also envisioned.

The end effector 100 has a pair of opposing jaws 120, 130, eachpivotally connected to the clevis 110. FIG. 1 shows the jaws in theclevis-aligned, closed position and FIG. 2 shows one jaw in aclevis-aligned, extended open position. As will be describe below inmore detail, this particular open position is referred to as “extended”because it is exaggerated from a desired fully-open position of the jaws120, 130.

The cutting actuation wire 10 is connected at its distal end to acutting assembly 140, which is best seen in FIG. 5 and includes a bladebody 150, a blade lock bias device 160, and a blade control device 170.More specifically, the distal end of the cutting actuation wire 10 isconnected to the proximal end of the blade body 150. An intermediateportion of the blade body 150 defines a control slot 152, which will bedescribed in further detail below. The blade body 150 has a distal endat which is a cutting blade 154. Here, the blade 154 is perpendicular tothe longitudinal axis of the blade body 150 but, in other exemplaryembodiments, can be at an angle thereto. Extending from the blade body150 is at least one blade boss 156. See, e.g., FIG. 2. In one exemplaryembodiment, there are two opposing and identical blade bosses 156, oneon either side of the blade body 150.

The blade 154 is positioned within the jaws 120, 130 to cut tissuetherebetween and, in particular, before, during, and/or after thecautery jaws 120, 130 have sealed the tissue on either side of the cut.To insure that the blade 154 does not extend distally until the userdesires such extension, a non-illustrated bias device in the actuationhandle imparts a proximally directed bias at all times. When the userdesires to extend the blade 154 distally, the user actuates the bladeextension control and overcomes the proximally directed bias of thisactuation handle bias device. The proximally directed bias is a forcesufficient to keep the blade body 150 in the proximal-most positionwithin the end effector 100 but not enough to cause damage to the bladeassembly or to the end effector 100.

The cutting assembly 140 includes its own bias device 160 for lockingthe blade body 150 dependent upon a current position of the jaws 120,130, and which is explained along with the blade control device 170. Asshown in FIG. 3, the blade control device 170 resides within the controlslot 152 of the blade body 150. The blade control device 170 has aproximal surface 172 oriented orthogonal to the longitudinal axis of theblade body 150, and, in this exemplary embodiment, also orthogonal tothe longitudinal axis of the end effector 100. This orientation of theproximal surface 172 provides a bearing surface for the distal end 162of the blade lock bias device 160, which, in this exemplary embodiment,is a compression spring. The blade control device 170 also has a distalend with a distal bearing surface 174 having a shape corresponding withthe interior shape of the distal end of the control slot 152. Here, thetwo shapes are curved, in particular, semi-circular. These shapes cantake any form, even angular or pointed, and can even be different. Allthat is needed in this cooperative engagement is for the distal end ofthe control slot 152 to be able to impart a force on the distal bearingsurface 174 when the blade body 150 is moved proximally to, thereby,correspondingly move the blade control device 170 along with the bladebody 150. The blade lock bias device 160 is positioned and pre-tensionedto force the blade control device 170 towards and/or into the distal endof the control slot 152.

Because the size of the end effector 100 is about 3.2 mm in diameter orless, the end effector parts are very small. A blade 154 having fewmillimeters in length and less for its height can be easily forced frombetween the jaws 120, 130 and/or bent if it is not properly protected.To prevent undesirable orientations and/or conditions from occurring,each of the jaws 120, 130 is provided with an internal blade controltrough 132, shown in FIG. 2, for example. This trough 132 provides aguiding surface along which the blade body 150 can move and betweenwhich the blade 154 travels. It is desirable for the blade body 150 andblade 154 to travel in the respective troughs of the jaws 120, 130substantially without friction. It is not necessary for a part of theblade body 150 to touch the control trough 132 so long as the trough 132provides a position-limiting area for the blade body 150 in thelongitudinal and transverse directions. If the blade body 150 and/orblade 154 is permitted to move distally while the jaws 120, 130 are opento such an extent that the blade 154 is no longer within the troughs,then forces from the environment, for example, imparted from tissuepresent between the jaws 120, 130, can cause undesirable lateralmovement of the blade 154 or blade body 150. With such small dimensions,even a small amount of lateral movement could damage the blade body 150and/or the blade 154 and, if plastically bent in the lateral direction,could prevent the jaws 120, 130 from closing—which would prevent the endeffector 100 from being removed, for example, from a channel in whichthe control shaft is present, such as when in a lumen of a trocar or amulti-channel endoscope. The bosses 156 and the blade control device 170are present for this desired control.

FIG. 2 shows the end effector 100 with the lower jaw 120 removed. Inthis figure, it is possible to see the distal shape of the clevis 110,especially near the bosses 156 at the distal end of the blade body 150near the blade 154. It can be seen that a boss stop cavity 112 ispresent and has an interior shape corresponding to the exterior shape ofthe boss 156. If a boss 156 is present on both sides of the blade 154,then a corresponding boss stop cavity 112 is present in a mannercorresponding to the configuration illustrated in FIG. 5, for example,but on the other side of the blade 154. The boss stop cavities 112provide a secure position for the blade 154 and blade body 150 when theblade body 150 is biased in the proximal direction. As can be seen, thecavities 112 prevent the blade from moving up or down in the plane ofthe blade 154 and the cavity in which the blade 154 is present in theclevis 110 prevents rotation of the blade 154 or blade body 150 therein.

As stated above, it is desirable for the blade 154 to be disposed withinthe troughs of the jaws 120, 130 at all times when it is extended fromthe retracted position shown in FIG. 2, for example. In order to providethis control, reference is made to FIGS. 6 to 9. As can be seen in FIG.6, a blade-extension control boss 134 on the interior side of each jaw120, 130 provides a blocking surface 136 that is absent from the travelline of the blade boss 156 as the blade 154 is extended because the jaws120, 130 are substantially closed and in-line with the outer surface ofthe clevis 110. In this closed orientation, if it is desired to extendthe blade body 150 between the jaws, the bosses 134 would not preventsuch movement. As shown in FIG. 6, the blade-extension control boss 134has a jaw-max-open control surface 138 at a distance from the bottom ofthe boss cavity 112. As such, the jaw 130 can be moved from the closedposition of FIG. 6 to the max-open position of FIG. 7 and still permitdistal movement of the blade 154. As used herein, the “max-openposition” of the jaws is a position where the jaws are open and theblade 154 is still protected within the troughs of the jaws 120, 130.So, if the jaw(s) is(are) open at the max-open position of FIGS. 7 and8, then the blade 154 can be extended to its fully distal position shownin FIG. 8. As is clearly shown, the blade 154 still resides within thecontrol trough 132. In this distal-most position, it becomes apparentthat the jaw 130 has a second proximal control device 139 (see FIG. 8)extending proximally from the proximal end of the jaw 130. In anyextended position of the blade 154, the second proximal control device139 is in a position where it does not block distal movement of theblade control device 170. In other words, from the closed position ofthe jaws 120, 130 to the max-open position of the jaws 120, 130, thesecond proximal control device 139 remains below (as viewed in FIG. 8)the blade control device 170.

In contrast to the above, when the jaws 120, 130 are open past themax-open position, the blade 154 should not be allowed to extend outfrom the clevis 110. The feature of the end effector 100 that preventssuch extension from occurring is, for example, the blade-extensioncontrol boss 134. As the jaws 120, 130 open past the max-open position,the blade-extension control boss 134 necessarily moves directly distal(in front of) the blade boss 156 as shown in FIG. 9. In thisorientation, the blade 154 is prevented from distal movement by theblade-extension control boss 134.

As the blade body 150 moves distally, the blade control device 170,forced distally by the blade lock bias device 160, moves distally alongwith the position of the distal end of the control slot 152. As bestshown in FIGS. 4 and 11, the blade control device 170 has at least onetransverse portion 172 extending orthogonal to the longitudinal axis ofthe end effector 100, for example, in the same direction as the bladeboss 156. As such, the blade control device 170 can move distallyforward along with the blade body 150, but only for a limited distance.Each of the jaws 120, 130 has the second proximal control device 139 asshown in FIG. 9. Therefore, with the second proximal control device 139directly distal of the transverse portion 172, the blade control device170 is not permitted to move distal of the position shown in FIG. 9.When both of the jaws 120, 130 are within their respective max-openpositions, the blade body 150 can move distally. See FIG. 8, forexample. More specifically, when the blade control device 170 movesforward from the disengaged position, for example, shown in FIG. 7, tothe engaged position, for example, shown in FIG. 8, each jaw 120, 130 isprevented from opening any further than the max-open position. Theadvantageous feature allowing the blade body 150 to extend distally whenthe jaws 120, 130 are open less than the max-open position is presentedby balancing the relative positions of the blade bosses 156 and theradial location of the second proximal control devices 139 on each ofthe jaws 120, 130.

Another advantageous feature of the end effector 100 is that the jaws120, 130 can pivot, in the plane of the blade 154, while the blade 154is extended. As apparent in FIG. 8, the jaw 130 can “rock” upwards fromthe down-most position until it is prevented from further upwardmovement by the interior surface 137 of the tang of jaw 130. Thispermitted rocking movement is especially advantageous for trackingwithin a channel of an endoscope, for example. The second proximalcontrol device 139 also acts to limit the opening extent of each jawwhen the blade body 150 is extended in any amount.

The end effector 100 described herein can be used as a medicalcauterization device, in addition to a cutting device. This means that,to cauterize tissue between the jaws 120, 130, it is desired to passcurrent between the two opposing tissue-contacting inner jaw faces 135.If the parts touching the jaws 120, 130 were not appropriatelyinsulated, then current would pass between the jaws 120, 130 in a shortcircuit. To prevent such short-circuiting from occurring, in thisexemplary embodiment, various end effector parts are insulated. First,with respect to the embodiment illustrated in FIGS. 1 to 11, it is notedthat each of the two jaw actuation wires 20, 30 is used to pass currentto the respective connecting jaw 120, 130. To prevent electrical shortcircuiting of these wires 20, 30 from the non-illustrated proximalcontrol handle to the end effector 100, the wires 20, 30 are providedwith an electrical insulator over their entire extent except for thenon-illustrated connections at the control handle and the electricalconnection portions 32 adjacent the tangs of the jaws 120, 130. Theinsulator can be of any appropriate electrically insulating material,for example, a coating or a deposition. The clevis 110 is also providedwith an electrical insulator on all or part of its exterior surface. Ifthe entire clevis 110 is so coated, there is no chance ofshort-circuiting the electrical current passing through the wires 20,30. Similarly, at least the blade body 150 is provided with theelectrical insulation. With such insulation, the possibility of passingcurrent through the cutting actuation wire 10 is prevented, orsubstantially eliminated. If desired, the bias device 160 can beelectrically insulated as well. At this point, electrical current can bepresented to the entirety of the jaws 120, 130. By selective placementof an electrical insulator, the electrical current can be made to passonly through the inner faces 135 of the jaws 120, 130. Morespecifically, if the entirety of the jaws 120, 130 except for the innerjaw faces 135 is provided with an electrical insulator, then anyelectrical current passing between the wires 20, 30 will only passbetween the two opposing faces 135. To insure that current does not passfrom either jaw 120, 130 to the clevis 110 at the jaw pivot bosses 114,especially where the jaws 120, 130 have frictional contact with thepivot bosses 114, a jaw pivot bushing 180 made of an electricalinsulating material or covered with such a material is provided betweenthe respective jaw 120, 130 and pivot boss 114. See, e.g., FIG. 10.

One exemplary embodiment for insulating the wires 20, 30 includes apolyamide coating. An exemplary embodiment for providing insulated jaws120, 130, includes an anodized hardcoat of polytetrafluoroethylene(PTFE) with the inner jaw faces 135 having the coating removed or withthe jaws 120, 130 coated everywhere except the faces 135. Anotherexemplary embodiment for such a coating is a hard-coat anodization,which will provide wear resistance and lubricity where present.

The actuation assemblies of the present invention reduce the number ofsteps to effect the sealing and cutting surgical procedure. Thisimprovement is illustrated and explained with respect to FIG. 12, inwhich four steps are illustrated to perform an electrocautery sealingand cutting procedure with the invention. With the device jaws in thenormally open position, in Step 1, the surgeon closes the jaws byactuating a main lever. With the first pulling motion, the jaws closeand impart the sealing force to the tissue or vessel. In Step 2, thesurgeon actuates electrocautery and seals the tissue. In Step 3, thesurgeon pulls a trigger to move the cutting blade distally and thesealed tissue is cut. Typically, the blade is retracted upon release ofthe trigger. The surgeon, in Step 4, if desired, repeats the process(dashed line).

It is beneficial if electrocautery is effected when tissue is at anoptimal state for a desirable medical change to occur after the sealingand cutting procedure. Therefore, within the steps of compressing thetissue and carrying out electrocautery for sealing (but before cutting),the device can be configured to carry out an OTC-determination step.This determination can be carried out in various ways. In one exemplaryembodiment according to the invention, electrodes on either side of thetissue sense an impedance of the tissue disposed between the jaws (e.g.,at the jaw mouth surfaces). OTC can be determined by comparing themeasured impedance to a known range of impedances value corresponding toan OTC state of the tissue. As the tissue desiccates, the impedance ofthe tissue changes. Therefore, the active feedback circuitry can beprovided to continuously monitor the impedance and to indicate to thesurgeon to open or close the jaws accordingly (with appropriateindicators at the control handle, e.g., ↑=open or ↓=close) so that theOTC state is maintained up to and including the time that sealing andcutting is performed.

The OTC feedback device performs particularly well when coupled to amechanism for closing and opening the jaws. Passing an upper OTC valuein a positive direction means that too much pressure is being impartedon the tissue and the motorized jaws are opened to an extent that bringsthe measured value back within the OTC range. In contrast, passing thelower OTC value in a negative direction means that too little pressureis being imparted on the tissue and the motorized jaws are closed to anextent that brings the measured value back within the OTC range. Thisself-adjusting compression device keeps compression force on theinterposed tissue within the OTC compression range during and afterdesiccation. When in the OTC range after desiccation, the devicenotifies the surgeon of this fact, referred to as a “procedure-readystate.” With this information, a delay can be pre-programmed in thedevice so that the sealing does not occur until after a time periodexpires, for example, any amount of time up to 5 seconds. In oneexemplary embodiment, if the actuation device is pressed again, then theprocedure is aborted and the surgeon can reposition the jaws or entirelyabort the operation. If the surgeon does nothing during the delayperiod, then the device automatically starts the sealing procedure.Indicating information for the procedure-ready state can be conveyed tothe surgeon audibly (e.g., with a speaker), visually (e.g., with anLED), or tactilely (e.g., with a vibration device).

In another exemplary embodiment of the device, the end effector ispassively articulated with respect to the shaft/handle of the device asdescribed in U.S. Pat. Nos. 7,404,508 and 7,491,080, previouslyincorporated by reference. FIGS. 13 to 16 illustrate a first exemplaryembodiment of a distal end of a passive articulating electrocauterysealing and cutting surgical end effector 1300 of the present invention.The end effector 1300 has an articulation joint 1302 in an aligned orcentered articulation position (as compared to FIG. 17, which shows thearticulation joint of the invention in a left-articulated position).

In this exemplary embodiment of the articulation device, a distalarticulation joint portion 1310 also acts as a jaw clevis 1312 and aproximal articulation joint portion 1320 is formed from upper and lowerproximal articulation parts 1322, 1324. These parts 1322 and 1324 arefixed to the distal end of an outer shaft or sleeve 1330, which connectsa non-illustrated control handle to the end effector 1300.Electrocautery jaws 1340, 1342 are attached rotatably to the jaw clevis1312. A cutting blade 1350 is disposed between the jaws 1340, 1342 andrides within blade control troughs 1341, 1343 similar to trough 132 ofthe embodiment of FIGS. 1 to 11 to prevent the blade 1350 from beingdisplaced laterally to an impermissible extent. Control of each of thejaws 1340, 1342 is effected, first (in a proximal direction) by arespective link 1360, 1562 rotatably connected to each of the jaws 1340,1342. The link connection point is located offset from the pivot point1314 or, in the embodiment show, the pivot boss. The boss 1314 extendsfrom the clevis 1312 and through or inside a pivot hole of therespective jaw 1340, 1342. With appropriate fastening, the jaw 1340,1342 remains pivotally connected about the pivot point 1314. A similarjaw boss extends, parallel to the axis of the pivot hole, from the jaw1340, 1342. A distal end of the link 1360, 1562 is mounted pivotallyabout this jaw boss. In such a configuration, force exerted upon theproximal end of the link 1360, 1562 will pivot a respective jaw aboutits own pivot point 1314.

The proximal end of the link 1360, 1562 is pivotally connected to a jawdrive block 1370 disposed slidably within the distal articulation jointportion 1310. Like the jaws 1340, 1342, the block 1370 has a drive bossextending therefrom through a proximal boss hole of the link 1360, 1562.With the link 1360, 1562 secured in this manner, any longitudinalmovement of the block 1370 within the distal articulation joint portion1310 will cause a pivoting motion of each the jaws 1340, 1342, therebycausing jaw opening and closing movements. The exemplary boss-and-holeconnections mentioned above are only included as example connections andany similar kind of connection, including reversal of the connection isenvisioned for the invention.

With the distal articulation joint portion 1310 removed, it is apparentin FIG. 14 that the jaw drive block 1370 is connected at its proximalend to a jaw actuator 1390 that, in this illustration is arectangular-cross-sectioned drive band. This band 1390 is flexible, atleast in the distal portion including the articulation joint, so thatarticulation of the end effector 1300 can occur. Also apparent in FIG.14 is the control portion 1352 of the blade 1350, which, like the jawactuator 1390, is flexible, at least in the distal portion including thearticulation joint, and extends proximally back to the respectiveactuator at the device's control handle.

To support both the band 1390 and the control portion 1352 of the blade1350 within the proximal articulation joint portion 1320 (partiallyremoved and partially transparent in FIG. 14), a support block 1426 isprovided. This support block 1426 can have one groove in which tosupport the controls 1352, 1390 (in which it would have across-sectional II-shape), two grooves in which to support the controls1352, 1390 (in which it would have a cross-sectional H-shape), two holesin which to support the controls 1352, 1390 (in which it would have abisected vertically disposed rectangular cross-sectional shape), or anyother similarly functioning configuration. In the illustration shown,the support block 1426 is the first exemplary shape.

To support both the band 1390 and the control portion 1352 of the blade1350 within the articulating portion of the joint 1302, an articulationsupport 1480 is provided. The articulation support 1480, in a preferredembodiment, is similar to the dogbone 1080 present in the articulationjoint of the devices shown in U.S. Pat. Nos. 7,404,508 and 7,491,080(see, e.g., FIGS. 62 and 66 therein), in that it has a groove to supportrods/bands passing therethrough but is different, at least, in that thearticulation support 1480 is H-shaped to define separate upper and lowersupporting chambers for each of the two controls 1352, 1390 toelectrically insulate the bands from one another. Functioning of thearticulation support 1480 is best shown with respect to FIGS. 16 and 17.

When the articulation joint 1302 is aligned or straight, the controls1352, 1390 are also straight within the articulation joint 1302, asshown in FIGS. 14 to 16. In this orientation, the portions of thecontrols within the articulation joint 1302 do not touch any of theinner bearing surfaces of the articulation support 1480. These bearingsurfaces include left and right proximal surfaces 1620, 1621, left andright intermediate surfaces 1622, 1623, and left and right distalsurfaces 1624, 1625. When the articulation joint 1302 is articulated asshown in FIG. 17, for example, each of the controls 1352, 1390 touchesat least one of these surfaces 1620-1625. One of the controls 1352, 1390is shown diagrammatically with dashed lines in FIG. 17. Whenarticulated, the outer surface of the control 1352, 1390 touchesapproximately up to the entire outer intermediate surface 1622, 1623,which, in this illustration is the right intermediate surface 1623. Theleft intermediate surface 1622 is free from the touch of the control1352, 1390. In contrast, the control 1352, 1390 does not touch either ofthe outer proximal and distal surfaces 1621, 1625 (right in this case)but touches both of the inner proximal and distal surfaces 1620, 1624.The position shown in FIG. 17 is the far left articulated position ofarticulation joint 1302.

The proximal articulation joint portion 1320 and the distal articulationjoint portion 1310 define a chamber in which the support block 1426 iscontained. This chamber is best shown in FIGS. 16 and 17 and will beexplained with regard to FIG. 17. The distal articulation joint portion1310 define two opposing interior surfaces 1712, 1714 each at a similaracute angle with respect to the centerline of the distal articulationjoint portion 1310 and opening in the proximal direction. Likewise,together, the two portions 1322, 1324 of the proximal articulation jointportion 1320 define two similar opposing interior surfaces 1722, 1724each at a similar acute angle with respect to the centerline of theproximal articulation joint portion 1320 but opening in the distaldirection.

In the configuration of FIGS. 13 to 17, electrical conduction throughthe two jaws 1340, 1342 is accomplished by connecting one electricalpole to the proximal end of the jaw control band 1390 at thenon-illustrated control handle. In one exemplary embodiment, the controlband 1390 is insulated over its entire exterior surface with theexception of the proximal connection described and a portion at the jawdrive block 1370 where the control band 1390 is connected. In analternative exemplary embodiment, the control band 1390 is bare and allother surfaces are insulated. Electrical conduction through the link1360 is accomplished by electrically insulating the jaw drive block 1370all over its exterior surface except for the band 1390 connection andthe surface of the jaw drive block 1370 touching the proximal pivot ofthe link 1360. In one exemplary configuration, the outer surface of thejaw drive block 1370 boss and the proximal borehole inner surface of thelink 1360 are both be free from insulation. In the exemplaryconfiguration of the drawings, on the other hand, the jaw drive block1370 and the proximal borehole inner surface of the link 1360 are bothinsulated. In a similar manner, electrical conduction to the jaw 1340from the link 1360 can occur by, for example, by having an insulativecoating all over the lower jaw 1340 except for the inner surface of thejaw pivot hole and by not having insulative coating on the exterior ofthe jaw boss 1314. With an insulating sleeve 1442 electricallyseparating the jaw 1340 from the clevis 1312, electricity can beconducted to the jaw 1340. To insure that electricity from the jaw 1340does not conduct to anywhere other than the mouth surface 1444 of thejaw 1340, insulation is not present at least on a portion of the mouthsurface 1444.

In one exemplary embodiment of the second pole electrical conductionpath, the second electrical pole is connected electrically to theproximal end of a wire 1450 (illustrated diagrammatically by a dottedline in FIG. 14). The wire 1450 extends through the sleeve 1330 andthrough the articulation joint 1302 by any appropriate lumen present ineither part of the proximal articulation joint portion 1320 and in thedistal articulation joint portion 1310. By exiting at the clevis 1312near the pivot point of the jaw 1342, a small contact area can be leftfree from insulation and the wire 1450 connected there Like jaw 1340, toinsure that electricity from the jaw 1342 does not conduct to anywhereother than the mouth surface 1446 of the jaw 1342, insulation is notpresent at least on a portion of the mouth surface 1446.

In another exemplary embodiment of the second pole electrical conductionpath, the second electrical pole is connected electrically to theproximal end of the sleeve 1330, which is insulated from the jaw controlband 1390. The sleeve 1330 is electrically conductively connected to atleast one part 1322, 1324 of the proximal articulation joint portion1320. Next, the at least one part 1322, 1324 has a non-insulated surfaceelectrically conductively connected to a non-insulated surface of thedistal articulation joint portion 1310. For example, the lower surfaceof the upper part 1322 that slides on the upper surface of the distalarticulation joint portion 1310 can both be free from insulation andremain in electrical contact as the joint articulates. If the jaw 1340is insulated from the distal articulation joint portion 1310, then thesurface facing the proximal tang of the jaw 1342 and the proximal tangcan both be free from an insulating surface layer and, due to the directsliding connection therebetween, the jaw 1342 becomes electricallyconductively connected to the second pole. By insulating the remainderof the exterior surface of the jaw 1342 except for the mouth surface,the mouth surface becomes the only place that electricity can conductfrom jaw 1342 to jaw 1340. One exemplary embodiment of the insulativecoating for the above configuration is a TEFLON® hardcoat anodization.

FIGS. 18 to 28 show a first exemplary embodiment of a control handle1800 of the bipolar cautery and cutting device of the present invention.Within the first control handle housing 1802, is a jaw control trigger1810, a blade control trigger 1820, a blade-firing spool 1822, and apassive articulation lock control trigger 1830. A number oflumens/devices extend from the control handle 1800 to the end effectorof the invention. The outermost hollow lumen is the sleeve 1330.Coaxially disposed within the sleeve 1330 is a hollow passivearticulation lock lumen 1840. Coaxially disposed within the passivearticulation lock lumen 1840 is a hollow jaw control lumen 1850 andcoaxially disposed within the jaw control lumen 1850 is the distal endof the control portion 1352 of the blade 1350. Each of these devices canbe in any alternative form (e.g., rod, band, hollow lumen) as desired.

The jaw control trigger 1810 is pivotally connected inside the handle1800. The jaw control trigger 1810 has a cam surface 1812 against whicha jaw cam follower 1860 moves. The jaw cam follower 1860 is fixedlyconnected to the jaw control lumen 1850 in the longitudinal direction ofthe sleeve 1330 to cause the close/open movement of the jaws as the jawcontrol trigger 1810 is squeezed/released. An overforce protectiondevice 1870 is provided in the handle 1800 and limits the amount offorce that is imparted upon the jaw control lumen 1850 when closing thejaws. The overforce protection device 1870, in the exemplary embodimentshown, is disposed within the jaw cam follower 1860. Not illustrated inFIG. 18 is an overforce compression spring disposed between the jaw camfollower 1860 and an overforce adjustment knob 1872. The jaw controltrigger 1810 can be a simple squeeze trigger or a click-on/click-offdevice. FIG. 19 is an illustration of an exemplary embodiment of thelatter configuration.

FIG. 18 also illustrates a battery assembly 1880 contained within thegrip portion 1804 of the control handle 1800. FIGS. 20 and 21 illustrateone exemplary configuration of how the battery is placed within andremoved from the grip portion 1804. A trapdoor 2010 is mounted pivotallyat the bottom of the grip portion 1804 of the handle 1800. By pressing atrapdoor release button 2020, the trapdoor 2010 springs open, forexample, with the assistance of a non-illustrated torsion spring. At aside of the battery assembly 1880 (for example, the upper side) is afirst part 2080 of a connector assembly for removably securing thebattery assembly 1880 within the grip portion 1804 of the handle 1800.Within the handle 1800 is a second part 2082 of the connector assemblythat, together with the first part 2080, removably secures the batteryassembly 1880 within the grip portion 1804 and electrical connectscircuitry within the battery assembly 1880 to the jaws of the endeffector for supplying the radio-frequency signal thereto.

As shown in FIGS. 20 and 21, the battery assembly 1880 has a trapdoorflange 2090 that operatively interacts with a battery eject flange 2012at the pivoting end of the trapdoor 2010. In this configuration, whenthe trapdoor 2010 is released from its closed and locked position, thetorsion spring, depending on the magnitude of its spring constant, willautomatically eject the battery assembly 1880 from the handle grip 1804to a small or large distance. In the former configuration, it isdesirable for the battery to be ejected only partially so that theoperating room staff can easily grab the ejected battery from the handle1800 without touching the handle 1800 itself. In the latterconfiguration, the surgeon can place the handle grip 1804 over a batterydisposal container and, by pressing the trapdoor release button 2020,the battery assembly 1880 will be ejected from the handle 1800completely and will fall into the disposal container. As such, theoperating room staff can easily and quickly install a replacementbattery assembly 1880.

It is noted here that the handle 1800 and its internal components areentirely free from electronic circuitry. This is a unique andsignificant aspect of the invention. By placing all of the powergeneration, regulation, and control circuitry of the cautery device ofthe invention within the battery assembly 1880, the handle 1800 and endeffector 100, 1300 can be made with entirely low-cost and disposablecomponents. With such a configuration, all of the expensive circuitrycan be reused repeatedly, at least until the circuitry or battery fails.Under expected normal conditions, the life of the battery assembly 1880will extend to hundreds of uses.

FIGS. 22 to 28 illustrate operation of the handle 1800. In FIG. 22, thehandle 1800 is in its rest state with no triggers actuated. FIGS. 23 and24 show the jaw-closing trigger 1810 in intermediate and fully closedpositions, respectively. As can be seen from FIG. 22, the jaw camfollower 1860 moves back with the jaw control lumen 1850. The jaws arefully closed when the jaw cam follower 1860 is at the position shown inFIG. 23. The remaining distance travelled by the jaw-closing trigger1810 does not pull the jaw control lumen 1850 further proximally.Instead, the overforce protection device 1870 begins to actuate bycompressing the non-illustrated compression spring disposed between thejaw cam follower 1860 and the overforce adjustment knob 1872. Thisconfiguration insures that sufficient force is employed against tissuedisposed between the jaws of the end effector.

The view of FIG. 25 shows the jaw-closing trigger 1810 in the almostfully depressed position (locked by the device of FIG. 19, for example)and the blade control trigger 1820 also in the fully depressed position.When the blade control trigger 1820 is depressed, the uppermost end ofthe trigger 1820, resting inside a blade control spool 1822, movesdistally to carry the spool 1822 distally along the jaw control lumen1850. The spool 1822 is fixedly connected to the control portion 1352 ofthe blade 1350 through, for example, a pin 1824 that passes through thespool 1822 orthogonal to the spool axis and through the control portion1352. In this way, any movement of the spool 1822 is translated into acorresponding movement of the blade 1350. A clearance for the pin 1824is cut out of the bottom of the jaw control lumen 1850 as shown in FIGS.18, 25 and 26, for example. An exemplary embodiment of the jaw controllumen 1850 has the lumen in the shape of a rod from the proximal end(shown in FIGS. 25 and 26) all the way to the articulation joint, atwhich point it can be shaped as shown in FIGS. 14 to 17, for example. Avertical slot can be formed all the way along the bottom of the jawcontrol lumen 1850 to allow for slidable translation of the controlportion 1352 of the blade 1350 with respect to the jaw control lumen1850 and to the sleeve 1330. The vertical slot also adds lateral supportto the band-shaped control portion 1352 all along the extent of the jawcontrol lumen 1850.

As can be seen in FIG. 25, the blade control trigger 1820 has a proximalcam surface 2532 that fits into a cam recess 2512 when both triggers1810, 1820 are in their rest state as shown in FIGS. 18 and 27. However,when the jaw-closing trigger 1810 is depressed, as shown in FIG. 25, thecam surface 2532 cannot reside within the cam recess 2512. Thisconfiguration is advantageous to assist with retraction of the blade1350. If, for example, the blade 1350 were to stick inside tissuebetween the jaws after cutting, a proximally directed force on thecontrol portion 1352 would be needed to remove the blade 1350. Toeliminate the need for a separate blade return bias device, theinvention takes advantage of the relatively strong return bias device(non-illustrated) present for the jaw-closing trigger 1810. Thisdesigned “mis-alignment” of the cam surface 2532 and the cam recess 2512permits the jaw closing return bias device to retract the blade 1350automatically when the jaw-closing trigger 1810 is allowed to return toits rest position. As shown in the progression of FIGS. 25 to 26, returnof the depressed jaw-closing trigger 1810 presses the trigger 1810against the cam surface 2532 up until the cam surface 2532 returns, onceagain, into the cam recess 2512, as shown in FIG. 27.

At any time during the steps of tissue clamping, tissue cutting, andtrigger returning with the cautery/cutting device of the invention, thesurgeon is able to articulate the end effector 100, 1300 as desired.FIG. 28 illustrates an exemplary configuration for unlocking thearticulation joint to, thereafter, permit passive articulation of theend effector 100, 1300. The passive articulation lock control trigger1830 is operatively connected to a hollow articulation spool 2832, whicharticulation spool 2832 is longitudinally fixedly connected to thepassive articulation lock lumen 1840 and coaxial disposed andlongitudinally slidable with respect to the jaw control lumen 1850. Whenthe passive articulation lock control trigger 1830 is depressed, thearticulation spool 2832 translates proximally and moves the passivearticulation lock lumen 1840 correspondingly to remove an obstruction topassive articulation. An exemplary embodiment of such obstruction isdepicted in FIG. 29. There, the passive articulation lock lumen 1840 isshown within the sleeve 1330. The distal end of the passive articulationlock lumen 1840 defines an articulation lock cutout 2942 shaped tocorrespond to a proximal end of an articulation locking key 2944. Thelocking key 2944 can be press-fitted in the cutout 2942 or attachedtherein in any similar manner. With the locking key 2944 attached to theend of the passive articulation lock lumen 1840, any translation of thepassive articulation lock lumen 1840 will move the locking key 2944correspondingly. In the exemplary embodiment shown, the distal end ofthe locking key 2944 is formed with a protrusion 2946 shaped tointerlock with at least one keyhole located on the proximal end of thedistal articulation joint portion 1310. In this embodiment, there arethree keyholes 2912, 2913, 2914 to allow the end effector 100, 1300 tobe locked in one of three orientations. Of course, this number is notlimiting and neither is the placement of the keyholes 2912, 2913, 2914.Further, the key-keyhole configuration can be reversed as desired.

FIGS. 30 to 37 illustrate other exemplary configurations of a cordless,entirely self-contained cautery and cutting device of the invention. Thesecond control handle 3000, like the first control handle 1800, has ajaw control trigger 3010 and a blade control trigger 3020. Thisexemplary embodiment of the control handle 3000 has a shaft rotationknob 3030, which allows the surgeon to rotate the shaft and, thereby,the entire end effector assembly at the distal end of the device.Further, this exemplary embodiment is shown without a passivearticulation end effector but can include one as described herein. Insuch an embodiment, the knob 3030 can be pulled proximally sufficientlyfar to disengage the passive articulation lock, such as the locking key2944 described above. (The mechanism is described in detail in U.S. Pat.No. 7,491,080 to Smith et al., already incorporated herein by reference,and, therefore, it is not necessary to set forth, again, thisdisclosure.) Simply put, a small proximal movement of the knob 3030,retracts the locking key 2944 to permit passive articulation of thearticulation joint 1302 and release of the knob 3030 will allow the knob3030 to spring distally (under the force of a return bias device, e.g.,a compression spring) and re-engage the locking key 2944 with the distalarticulation joint portion 1310 to prevent further passive articulation.

Also present on this handle 3000 is a cautery firing trigger 3040. Withthe cautery firing trigger 3040 immediately above the blade controltrigger 3020, operation of the device is significantly simplified andergonomic. When operating this handle 3000, the surgeon depresses thejaw control trigger 3010, as shown in FIG. 32, to compress the tissuebetween the jaws. The jaw control trigger 3010 has a blade cam flange3112 and a proximal lever 3114. As shown in the progression from FIGS.31 to 32, depression of the jaw control trigger 3010 causes the bladecam flange 3112 to pivot counter-clockwise away from a blade shuttlepost 3142 of the blade shuttle 3144. Depression also causes the proximallever 3114 to pivot counter-clockwise and, via a link 3146, cause atrigger sled 3118 to move proximally. Without the blade cam flange 3112being moved from the rest position shown in FIG. 31, the cam surface3113 is in a position preventing the blade shuttle 3144 from movingdistally, thereby preventing any movement of the end effector bladeuntil the jaw control trigger 3010 is depressed.

With the jaw control trigger 3010 depressed, however, the blade shuttle3144 is free to move distally, such depression and movement being shownin FIG. 34. In this position, the blade shuttle post 3142 rests within aslot formed by the cam surface 3113 and is prevented from moving anyfurther distally. The distal end of the blade shuttle 3144 also has apin within a groove that limits distal movement of the blade shuttle3144 past the position shown in FIG. 34. A non-illustrated compressionspring is disposed to move the blade control trigger 3020 distally whenpressure is removed therefrom. If the blade is stuck in any way,proximal movement of the blade and blade shuttle 3144 may be haltedbefore returning to the rest position shown in FIG. 32, for example. Thecam surface 3113, however, is shaped to force the blade shuttle post3142 proximally any time the jaw control trigger 3010 returns to therest position shown, for example, in FIG. 30. This means that the jawcontrol trigger 3010 acts as a return assist for the blade and itsmovement assembly.

With the jaws compressing the tissue therebetween, cautery occurs bypresenting the index finger (for example) at the cautery-firing trigger3040 and depressing the cautery-firing trigger 3040. Without furthermovement of any part of the surgeon's single hand, the index finger canbe slid downward along the cautery-firing trigger 3040 and immediatelycontact the surface of the blade control trigger 3020. This slidingmovement of the finger can be quickly translated into a depressionmovement of the blade control trigger 3020 to cut the now-cauterizedtissue between the jaws, which is shown in FIG. 34. At this point, thesurgeon's fingers are relatively aligned with one another and aregrasping the blade-firing trigger 3020, the jaw control trigger 3010,and the grip portion 3004. To restart the process again, all that thesurgeon needs to do is to release the fingers holding the blade-firingtrigger 3020 and the jaw control trigger 3010 and to reposition the jawsabout the new tissue to be cauterized and cut. The process is, then,repeated as desired.

The battery assembly of the present invention is not simply a bipolarcauterization power supply. In prior art bipolar cautery devices, all ofthe power generation and regulation circuitry exists in expensivecounter-top boxes, each of which is required to be plugged into anelectric mains to function. A power distribution cord connects the priorart cautery device to the counter-top box, which cord limits the rangeof movement of the surgeon and adds cost to those devices. Theinvention, in contrast, entirely eliminates the need for the cord andthe counter-top box by providing a self-contained power supply andregulation device 1880, 3500, also referred to herein as the batteryassembly, which is explained with regard to FIGS. 34 and 35.

FIG. 34 shows a battery connection assembly with non-illustratedconductive traces connecting regulated power lines from a distributionpanel 3410 to the two electrical poles for each of end effector jaws.The distribution panel 3410 has a set of conductors 3420 to be connectedelectrically to individual supply ports 3512 of a supply array 3510. Atleast one power cell 3520 (e.g., a set of 2 to 6 lithium polymer cellshaving a high discharge current capacity on the order of 10-15 times therated storage capacity (known as 10-15 C) is electrically connected tovoltage control circuitry 3530, which can be, for example, a buck powersupply controlling the output signal voltage. Radio-frequency signalgenerating circuitry 3540 receives the output signal and converts itinto a high-frequency alternating-current signal, which AC signal issupplied to the end effector jaws through the conductive supply ports3512 and the distribution panel 3410.

With such a configuration, the control handle 3000 becomes entirely freefrom any power supply or power circuitry. This means that the relativelyexpensive supply and circuitry can be reused in the inventiveinterchangeable battery assembly 3500 and the relatively cheap handleparts of the mechanical control handle 3000 with its shaft and endeffector can be thrown away after the single operative use. If desired,the relatively expensive parts can be even further subdivided as shownin FIGS. 36 and 37. The battery assembly 3600 of these figures issimilar in function and shape to the battery assembly 3500. However, theradio-frequency signal generating circuitry 3540 is contained within aseparable signal processing sub-assembly 3640 having a set ofnon-illustrated circuit connection leads on a signal connectionsurface(s) 3642, which leads are connected to and from theradio-frequency signal generating circuitry 3540. If the twosub-assemblies 3620, 3640 of the battery assembly 3600 are each providedwith an appropriate part of a connection device, such as thetongue-and-groove configuration shown in FIG. 37, then the user has theability to replace either the battery/boost sub-assembly 3620 or thesignal processing sub-assembly 3640 as desired.

Even though it might be beneficial if the battery assembly 3500 ishermetically sealed for medical use (because the control handle definesan internal battery chamber 3406 that can be shut off from the asepticoperating environment), the battery assembly 3500 need not beautoclavable. An “aseptic seal” or “aseptically sealed,” as used herein,means a seal that sufficiently isolates a compartment (e.g., inside ahandle) and components disposed therein from a sterile field of anoperating environment into which the handle has been introduced so thatno microbiological organisms from one side of the seal are able totransfer to the other side of the seal. Further, “hermetic” or“hermetically sealed” means a seal or container that is substantiallyair tight and prevents microorganisms from passing across the seal orinto or out of the container.

With the control handle 3000 in the operating suite, operating staff canrequest circulating staff outside the aseptic field to insert thebattery assembly 3500 into the chamber 3406. The aseptic control handle3000 with the inserted battery assembly can be made entirely aseptic foruse in the operating room after operating staff closes the battery door3430, which door has a hermetic seal. Of course, the battery assembly3500 can be made to autoclave and, therefore, the battery assembly canbe brought into the sterile file as desired.

Like the first control handle 1800, the second control handle 3400 alsocan be provided with a battery assembly ejection device. As shown inFIGS. 33 and 34, the battery door 3430 is mounted pivotally to a lowerpart of the grip portion 3004 of the control handle 3400. By pressing atrapdoor release button 3320, the battery door 3430 springs open, forexample, with the assistance of a non-illustrated torsion spring. Asshown in FIGS. 33 and 34, the battery assembly 3500 has a door camsurface 3390 that operatively interacts with a battery eject flange 3312at the pivoting end of the battery door 3430. In this configuration,when the battery door 3430 is released from its closed and lockedposition, the torsion spring, depending on the magnitude of its springconstant, will automatically eject the battery assembly 3500 from thehandle grip 3004 to a small or large distance. As above, the batteryassembly 3500 can be ejected only partially so that the circulatingstaff can easily grab the ejected battery from the handle 1800 withouttouching the handle 1800 itself. Alternatively, any of the operatingstaff can place the handle grip 3004 over a battery disposal containerand, by pressing the trapdoor release button 3320, eject the batteryassembly 3500 from the handle 3000 completely, permitting it to fallinto the disposal container. As such, the operating/circulating roomstaff can easily and quickly install a replacement battery assembly3500.

The functional components of the embodiment of the third control handle3800 in FIGS. 38 to 43 are similar to the second control handle 3000. Inthis embodiment, however, the trigger mechanisms operate in a differentway and the radio-frequency signal generating circuitry 3840 is locatedin the disposable control handle 3800 and not within the batteryassembly 3880.

The third control handle 3800, like the first control handle 1800, has ajaw control trigger 3810, a blade control trigger 3820, and a gripportion 3804. Here, a blade return spring 3826 provides a distallydirected bias to keep a blade control spool 4022 in a proximal position(shown in FIG. 40, for example) and, thereby, the blade in a retractedposition.

Instead of an articulation lock trigger 1830, this embodiment has arotatable knob 3830. The shaft rotation knob 3830 allows the surgeon torotate the shaft and, thereby, the entire end effector assembly at thedistal end of the device. This exemplary embodiment is shown without apassive articulation end effector but can include one as describedherein.

Also present on this handle 3800 is a cautery-firing trigger 4240. Inthis embodiment, the cautery-firing trigger 4240 is immediately above athumb rest 4204 on the side of the grip portion 3804 of the controlhandle 3800. The cautery-firing trigger 4240 and the thumb rest 4204 canbe mirror symmetrical on both sides of the grip portion 3804.

The progression from FIGS. 38 to 41 reveals a novel multi-safety-triggerassembly that prevents the blade from firing unless and until the jawsare closed. This safety-trigger assembly includes the jaw controltrigger 3810, the blade control trigger 3820, a jaw trigger link 3812, ajaw trigger slide 3814, a jaw spool 3816, a blade control pivot 3822, ablade control pin 3824, a blade control spool 4022, and a jaw overforceprotection device 3850. This exemplary embodiment is shown without apassive articulation end effector but can include one as describedherein.

The jaw control trigger 3810 has an upper flange 3811 and a pivot 3912about which the jaw control trigger 3810 can be rotated. The proximalend of the upper flange 3811 is connected pivotally to a proximal end ofthe jaw trigger link 3812. The distal end of the jaw trigger link 3812is pivotally connected to a proximal portion of the jaw trigger slide3814. The jaw trigger slide 3814 has a guide track 3914 in which thepivot 3912 is disposed. The proximal end of the jaw trigger slide 3814has an upwardly projecting spool control flange 3918 engaged with thejaw spool 3816 to translate the jaw spool 3816 longitudinally as the jawtrigger slide 3814 translates longitudinally. To carry out the jawmovement motion (open/close), the surgeon exerts pressure upon the jawcontrol trigger 3810 towards the grip 3804 to pivot the jaw controltrigger 3810 about the pivot 3912 to the position shown in FIG. 39. Atthe same time, the jaw link 3812 pivots and exerts a proximally directedforce to the jaw trigger slide 3814 to move the jaw trigger slide 3814to the proximal position, also shown in FIG. 39. At the end of the jawlink 3812 movement, the distal end of the jaw link 3812 is higher thanthe proximal end of the jaw link 3812. This movement of the jaw triggerslide 3814 causes the jaw spool 3816 to translate proximately acorresponding amount. Closing movement of the jaws is effected becausethe jaw spool 3816 is longitudinally connected to a jaw movement lumen3990. With respect to the configuration shown in FIGS. 1 to 11, the jawmovement lumen 3990 is the jaw actuation wires 20, 30, and, with respectto the configuration shown in FIGS. 13 to 17, the jaw movement lumen3900 is the jaw actuator 1390.

The blade control trigger 3820 moves, initially, with the FIGS. 38 to 39movement of the jaw control trigger 3810 but does not cause any blademovement. A guide groove 3921 is present to prevent firing of the knifewhile the jaws remain open and the blade control trigger 3820 needs tobe moved out of the distal vertical portion of the guide groove 3921. Ascan be seen best in FIG. 41, the guide groove 3921 does not allow theblade control trigger 3820 to move proximally until it enters a lowerhorizontal portion of the guide groove 3921, and entry cannot occuruntil the jaw control trigger 3810 is also in the horizontal positionshown in FIGS. 39 to 41; thus, the invention ensures that the jaws areclosed when the blade is required to move. Actuation of the bladecontrol trigger 3820 from the position shown in FIG. 39 to the positionshown in FIG. 40 removes the safety that prevents firing of the blade.When in the position of FIG. 40, the blade control trigger 3820 can nowbe translated longitudinally proximally (i.e., not in a circular motionabout its pivot) from the position shown in FIG. 40 to the positionshown in FIG. 41.

Present on the jaw control trigger 3810 is a blade actuation boss 3813(which is shown within a boss groove 4024 hidden behind a lower portionof the blade control pivot 3822 in FIG. 40). As the blade controltrigger 3820 (along with jaw control trigger 3810) is moved proximally,the blade actuation boss 3813 carries/transports/moves the lower end ofthe blade control pivot 3822 about its pivot point in acounter-clockwise direction. Correspondingly, the upper portion of theblade control pivot 3822, with its pin groove 4026 carrying the bladecontrol pin 3824, is moved counter-clockwise about the pivot point ofthe blade control pivot 3822. The blade control pivot 3822 is forked atthe upper portion to accommodate the blade control spool 4022 thereinand to capture the blade control spool 4022 so that the blade controlspool 4022 moves distally when the blade control pin 3824 is moved. Theblade control spool 4022 is connected longitudinally to the blademovement lumen 4052 that causes the distal/proximal movement of theblade. With respect to the configuration shown in FIGS. 1 to 11, theblade movement lumen 4052 is the cutting actuation wire 10 and, withrespect to the configuration shown in FIGS. 13 to 17, the blade movementlumen 4052 is the control portion 1352 of the blade 1350.

Operation of the device is significantly simplified and ergonomic. Whenoperating this handle 3800, the surgeon depresses the jaw controltrigger 3810 as shown in FIG. 39. The blade control trigger 3820 followsthe movement of the jaw control trigger 3810 without actuating theblade. With the jaws compressing the tissue therebetween, cautery occursby presenting the thumb (for example) at the cautery-firing trigger 4240and depressing the cautery-firing trigger 4240. Next, as shown from thetransition from FIG. 39 to FIG. 40, the blade control trigger 3820 isdepressed. This action does not move the blade, however. Instead, itmerely acts to unlock an ability to move the blade; in essence, it is asafety release. With the blade control trigger 3820 in the depressedposition, the combined sub-assembly of the jaw control trigger 3810 andthe blade control trigger 3820 can be moved proximally, as shown by thetransition from FIG. 40 to FIG. 41. Such movement is not circular (asare the other embodiments described above). Rather, the movement islinear. With such linear movement, a corresponding movement of the bladeand cutting of the now-cauterized tissue between the jaws is carriedout. At this point, the surgeon's fingers are relatively aligned withone another and are grasping the blade-firing trigger 3020, the jawcontrol trigger 3010, and the grip portion 3004. To restart the processagain, all that the surgeon needs to do is to release the fingersholding the blade firing and jaw control triggers 3020, 3010 (or pushthe fingers holding the triggers 3020, 3010 distally) and reposition thejaws about the new tissue to be cauterized and cut. The process is,then, repeated as desired.

Like the configuration of FIGS. 30 to 34, the battery assembly 3880 isremovable from a compartment 4305 within the grip portion 3804 of thecontrol handle 3800 and is interchangeable with other similar batteryassemblies 3880. Ejection of the battery assembly 3880 can be carriedout, for example, with a battery ejection assembly similar to thebattery ejection assembly 2010, 2012, 2090 shown in FIGS. 20 and 21, butother similarly functioning assemblies can be employed as well. Unlikethe configuration of FIGS. 30 to 34, the radio-frequency signalgenerating circuitry 3840 is not contained within the battery assembly3880. Instead, it is located in a proximal location within the upperportion of the control handle 3800. (Of course, the circuitry 3840 canbe located anywhere in the control handle 3800 in this embodiment.) Insuch a configuration, the radio-frequency signal generating circuitry3840 can be disposed when the control handle 3800 is discarded.

In an advantageous alternative exemplary embodiment of theradio-frequency signal generating circuitry 3840 and disposable controlhandle 3800, the control handle 4400 has a removable and interchangeablecircuit casing 4406, which is hermetically sealed and autoclavable. Thecircuit casing 4406 houses the radio-frequency signal generatingcircuitry 3840 and, therefore, enables the reuse of this circuitry 3840.Electrical connection of the radio-frequency signal generating circuitry3840 can be effected with leads 4608, for example, made of gold-platedcopper. Removable connection of the circuit casing 4406 can be made bymany mechanical configurations. For example, a T-slide connection, atongue-and-groove connection, a press-fit connection, and even amagnetic connection.

FIGS. 47 to 50 illustrate another exemplary embodiment of a distal endof an electrocautery sealing and cutting surgical end effector 4700 ofthe present invention. This end effector 4700 is not shown with anarticulation joint although the articulation joint of the invention canbe employed here equally. This embodiment acknowledges characteristicsof forming the jaws 4710, 4720 from a solid piece of material and, basedthereupon, forms each of the jaws 4710, 4720 from two pieces ofdifferent materials—the outer piece 4712, 4722 being of a materialhaving good heat insulating properties and the inner piece 4714, 4724being of a material having good strength properties. Each of the innerpieces 4714, 4724 has a mouth surface 4716, 4726 coated with anelectrically conductive material to provide the radio-frequency signalto tissue disposed between the jaws 4710, 4720. For example, theconductor material can be plates of stainless steel or gold-coatedcopper. Electricity is presented to the mouth surfaces 4716, 4726through portions of the end effector 4700 as in the previously describedembodiments or, in the exemplary embodiment shown, through two insulatedwires 4730, 4740 shown, respectively with differently dashed lines. Eachof the wires 4730, 4740 terminates at a jaw connection 4718, 5028 andthe wire is electrically connected to the conductive coating of themouth surfaces 4716, 4726.

FIGS. 51 to 53 illustrate another exemplary embodiment of a distal endof a passively articulating electrocautery sealing and cutting surgicalend effector 5100 of the present invention. This end effector 5100 isshown with an articulation joint but the articulation joint can beremoved if desired. Like the embodiment of FIGS. 47 to 50, thisembodiment acknowledges the characteristics of forming the jaws 5110,5120 from a solid piece of material and, instead, forms each of the jaws5110, 5120 from two pieces of different materials with the outer piece5112, 5122 being of a material having good heat insulating propertiesand the inner piece 5114, 5124 being of a material having good strengthproperties. Each of the inner pieces 5114, 5124 has a conductive mouthsurface providing the radio-frequency signal to tissue disposed betweenthe jaws 5110, 5120. For example, the conductor material can be platesof stainless steel and the outer piece 5112, 5122 can be stainless steelwith an insulating covering. Electricity is presented to the mouthsurfaces through portions of the end effector 5100 as in the previouslydescribed embodiments or, in the exemplary embodiment shown, through twoinsulated wires 5140 illustrated, respectively, with differently dashedlines. Each of the wires 5140 terminates at a jaw connection 5118, 5128and is electrically connected to the conductive coating of the mouthsurfaces of the inner pieces 5114, 5124.

In contrast to the previous end effector embodiments where the jaws haveindependent pivoting devices, the end effector 5100 includes a singlejaw pivoting assembly. In this embodiment, each side of the clevis 5130has a jaw pivot slot 5132 in which slides a jaw pivot rod 5134. As bestshown in FIG. 53, the proximal portion of each of the jaws 5110, 5120defines a control slot 5326, 5328 in which the jaw pivot rod 5134slides. A jaw control rod 5330 is connected longitudinally to the jawpivot rod 5134 and longitudinal movement of the jaw control rod 5330causes the jaw pivot rod 5134 to slide along the jaw pivot slot 5132 andmove correspondingly within the control slots 5326, 5328 of the jaws5110, 5120. As shown in FIGS. 51 to 53, distal movement of the jawcontrol rod 5330 opens the jaws 5110, 5120 and proximal movement of thejaw control rod 5330 closes the jaws 5110, 5120.

Articulation of the end effector 5100 is carried out at a controlhandle. When a passive articulation lock control trigger is actuated, apassive articulation lock lumen 5340 is moved proximally to remove anobstruction to passive articulation. An exemplary embodiment of suchobstruction is depicted in FIGS. 52 and 53. There, the passivearticulation lock lumen 5340 is shown within the sleeve 1330. The distalend of the passive articulation lock lumen 5340 defines an articulationlock cutout 5342 shaped to correspond to a proximal end of anarticulation locking key 5344. The locking key 5344 can be press-fittedin the cutout 5342 or attached therein in any similar manner. With thelocking key 5344 attached to the end of the passive articulation locklumen 5340, any translation of the passive articulation lock lumen 5340will move the locking key 5344 correspondingly. In the exemplaryembodiment shown, the distal end of the locking key 5344 is formed witha protrusion 5346 shaped to interlock with at least one keyhole locatedon the proximal end of the clevis 5130. In this embodiment, there arethree keyholes 5332, 5333, 5334 to allow the end effector 5100 to belocked in one of three orientations. Of course, this number is notlimiting and neither is the placement of the keyholes 5332, 5333, 5334.Further, the key-keyhole configuration can be reversed as desired.

The embodiments discussed above each include manual actuation of thegrasping and cutting sub-assemblies. FIGS. 54 to 60 illustrate anembodiment where the jaw movement mechanism is manual and the blademovement mechanism is electrically powered and controlled. FIGS. 61 to64 illustrate an embodiment where the jaw and blade movement mechanismsare both electrically powered and controlled. Thus, any strenuous handactivity by the surgeon required during the cauterization/cuttingprocedure for prior art devices is substantially reduced or entirelyeliminated. In all of these figures, the end effector is removed forclarity. FIGS. 65 to 67 illustrate how the electronically controlledgrasping and cutting device of the present invention reduces the numberof steps required to carry out a single cauterization/cutting procedure.

In the exemplary embodiment of the blade-powered device 5400 of FIGS. 54to 57, a non-illustrated removable battery is inserted into a batterycompartment 5405 within a handle portion 5404 of the device 5400. A jawcontrol trigger 5410 is pivotally connected to the device 5400 and has aflange 5412 pivotally connected to an end of a jaw control rod 5490.Thus, pivoting movement of the jaw control trigger 5410 causes alongitudinal translation movement of the jaw control rod 5490. The jawcontrol rod 5490 is longitudinally connected to a manual jaw slide 5492,which is shown by itself in FIG. 55. Behind the mount 5494 is aconnection that causes a corresponding translation of the jaw actuator1390 with any movement of the manual jaw slide 5492.

The manual jaw slide 5492 is slidably disposed upon a blade controlslide 5422, shown by itself in FIG. 56. Both the manual jaw slide 5492and the blade control slide 5422 are shown separate from the device 5400in FIG. 57. As shown in FIG. 57, the blade control slide 5422 has aprotruding boss 5426 that allows interaction of the blade control slide5422 with the manual jaw slide 5492. In particular, closing of the jawsby a distal movement of the manual jaw slide 5492 results in a partialdistal movement of the blade control slide 5422.

Movement of these parts and control of the both the blade and jawmechanisms are illustrated in FIGS. 58 to 60. In FIG. 58, the jawcontrol trigger 5410 is removed. In the proximally disposed orientationof both the manual jaw slide 5492 and the blade control slide 5422 inFIG. 58, the jaws are open and the blade is retracted. With a depressionof the jaw control trigger 5410, the jaw control rod 5490 movesdistally, causing the jaw actuator 1390 to move distally and close thejaws. The jaw control trigger 5410 has a sensor 5414 that detects afully depressed position thereof. When this sensor 5414 (e.g., amicroswitch) is actuated or detects the fully depressed position, ajaws-closed state is recognized, thereby indicating that the blade canbe moved safely within the jaws of the end effector. As such,electronics 5440 connected to the sensor 5414 powers the cautery deviceto deliver energy to the tissue disposed between the jaws. When thecauterization process is complete, tissue cutting can commence. Theelectronics 5440 detects this state and actuates a blade control servo5420. In the exemplary embodiment shown, actuation of the blade controlservo 5420 causes a counter-clockwise rotation of the blade movementcrank 5424, which, due to the steady positioning of the manual jaw slide5492, allows the blade control slide 5422 (along with the blade controlservo 5420) to move distally from the blade-retracted position shown inFIG. 59 to the blade-extended position shown in FIG. 60. Othernon-illustrated microswitches and/or circuitry can detect a completedblade extension and, thereafter, cause the blade control servo 5420 toreverse (clockwise movement) and, thereby, withdraw the blade from thecauterized tissue disposed between the jaws to complete the tissuecutting process. As shown, the blade movement crank 5424 remainssubstantially still as the jaws are closed.

A return spring 5496 can be disposed to bias the jaw control rod 5490distally to, thereby, cause jaw separation when the surgeon is notdepressing the jaw control trigger 5410. Similarly, the blade controlslide 5422 can be biased (e.g., spring-loaded) in a proximal directionto keep the blade in the retracted position when at a steady state andto assist in removal from cauterized tissue between the jaws when stuckthereto.

In the exemplary embodiment of the jaw-and-blade-powered device 6100 ofFIGS. 61 to 64, a non-illustrated removable battery is inserted into abattery compartment 6105 within a handle portion 6104 of the device6100. A jaw control trigger 6110 is pivotally connected to the device6100 but, in this embodiment, has no mechanical connection to control ofthe jaws. Instead, all control of the jaws occurs through a sensor 6114that detects one or more depressed positions of the jaw control trigger6110. When this sensor 6114 (e.g., a single or multi-positionmicroswitch) is actuated or detects a partially depressed position, itsends a signal corresponding to the state of compression to jaw controlcircuitry 6142, which, in turn, controls movement of a jaw-movementservo 6144.

If jaw control is dependent only upon a fully closed jaw control triggerposition, then the servo 6144 moves the jaws from the open to closedposition when the jaw control trigger 6110 is fully depressed. On theother hand, if jaw control is dependent upon a relative jaw controltrigger position, then the servo 6144 moves the jaws between thejaw-open to jaw-closed position corresponding to a degree of depressionof the jaw control trigger 6110. Either way, the circuitry 6142 causesthe jaw control servo 6144 to rotate the jaw movement crank 6146 (e.g.,counter-clockwise) and move the automatic jaw slide 6192 distally toeffect distal movement of the jaw actuator 1390, which, in turn, closesthe jaws. Thus, pivoting movement of the jaw control trigger 6110 causesa corresponding electronically controlled and regulated translation ofthe jaw actuator 1390. With appropriately positioned non-illustratedforce sensors, control of the jaw-movement servo 6144 can be regulatedto prevent compression force upon tissue disposed between the jaws fromexceeding a certain pre-set maximum value (and, conversely, can beregulated to insure compression force upon tissue disposed between thejaws exceeds a certain pre-set minimum value).

The automatic jaw slide 6192 is slidably disposed upon a blade controlslide 5422 in the device 6100. As in the blade-powered assembly of FIGS.54 to 60, closing of the jaws by distal movement of the automatic jawslide 6192 results in a partial distal movement of the blade controlslide 5422.

Movement of these parts and control of the both the blade and jawmechanisms are illustrated in FIGS. 62 to 64, in which, the jaw controltrigger 6110 is removed for clarity. In the proximally disposedorientation of both the automatic jaw slide 6192 and the blade controlslide 5422 in FIG. 62, the jaws are open and the blade is retracted.With a depression of the jaw control trigger 6110, the jaw controlcircuitry 6142 causes the jaw control servo 6144 to move the automaticjaw slide 6192 distally, causing the jaw actuator 1390 to move distallyand close the jaws, as shown from the progression from FIG. 62 to FIG.63.

With the jaws in a closed position (which can be detected by thecircuitry 6142), cautery electronics 6140, also connected to the sensor6114 and/or the jaw movement circuitry 6142, power the cautery portionsof the jaws to deliver energy to the tissue disposed therebetween. Whenthe cauterization process is complete, tissue cutting can commence. Thecautery electronics 6140 detects this end state and actuates a bladecontrol servo 5420. In the exemplary embodiment shown, actuation of theblade control servo 5420 causes a counter-clockwise rotation of theblade movement crank 5424, which, due to the steady positioning of theautomatic jaw slide 6192, allows the blade control slide 5422 (alongwith the blade control servo 5420) to move distally from theblade-retracted position shown in FIG. 63 to the blade-extended positionshown in FIG. 64. Other non-illustrated microswitches and/or circuitrycan detect a completed blade extension and, thereafter, cause the bladecontrol servo 5420 to reverse (clockwise movement) and, thereby,withdraw the blade from the cauterized tissue disposed between the jawsto complete the tissue cutting process. As shown, the blade movementcrank 5424 remains substantially still as the jaws are closed.

A return spring can be disposed to bias the jaw and blade servos 5402,6144 proximally to, thereby, cause jaw separation and retraction of theblade when the surgeon is not depressing the jaw control trigger 6110and/or to assist in removal of the blade from cauterized tissue betweenthe jaws when stuck thereto.

The exemplary embodiments with servo-controlled blade and/or jawassemblies are shown herein only with the power generation circuitry inthe handle. Nonetheless, these embodiments should not be consideredlimiting. All of the alternative and/or additional embodiments mentionedherein are applicable in any combination to each of these embodiments,for example, some circuitry can be placed in the battery itself or in aremovable cartridge.

The actuation assemblies of the present invention reduce the number ofsteps to effect the sealing and cutting surgical procedure. Thisimprovement is illustrated and explained with respect to FIGS. 65 to 67.To begin, FIG. 67 illustrates four steps that are needed to perform aprior art electrocautery sealing and cutting procedure. With the devicejaws in a normally open position, in Step 1, the surgeon closes the jawsby actuating a main lever. With the first pulling motion, the jaws closeand impart the sealing force to the tissue or vessel. In Step 2, thesurgeon actuates electrocautery and seals the tissue. In Step 3, thesurgeon pulls a trigger to move the cutting blade distally and thesealed tissue is cut. Typically, the blade is retracted upon release ofthe trigger. The surgeon, in Step 4, unlocks the main lever and, ifdesired, can repeat the process (dashed line). Each of Steps 1, 3 and 4,requires the surgeon to expend a significant amount of energy withhis/her hand. For surgical procedures taking a long time and requiring anumber of such sealings/cuttings, the surgeon can become tired.

The device of the invention, in contrast, dramatically reduces theforces required to effect the surgical procedure and, at the same time,reduces the total number of steps for completing the procedure—thecombination of which conserves energy needed to carry out proceduresover extended periods of time. This reduction is illustrated andexplained with respect to FIGS. 66 and 67. To begin the inventiveprocedure, the surgeon closes the jaws in Step 1 by actuating a mainlever 5410, 6110 of the device. With this first pulling motion, the jawsclose and impart a first intermediate sealing force to the tissue orvessel. Thereafter, in Step 2, the surgeon makes a single actuation(e.g., presses a button, moves a toggle, rolls a wheel) on the deviceand the entire surgical procedure is carried out automatically. Withrespect to a configuration where the unlocking of the main lever ismanual, only the sealing and cutting is performed automatically in Step2. The main lever is unlocked by the surgeon in Step 3. In contrast,when the main lever is also electrically operated, both Steps 2 and 3 ofFIG. 66 are performed with no other action than pressing theprocedure-actuation switch, which is not illustrated but can bepositioned on the side of the handle body similar to the button 4240 inFIG. 42.

It is beneficial if electrocautery is effected when tissue is at anoptimal state for a desirable medical change to occur after the sealingand cutting procedure. Therefore, within the steps of compressing thetissue and carrying out electrocautery for sealing (but before cutting),these exemplary devices can be configured to carry out anOTC-determination step. This determination can be carried out in variousways. In one exemplary embodiment according to the invention, electrodeson either side of the tissue sense an impedance of the tissue disposedbetween the jaws (e.g., at the jaw mouth surfaces). OTC can bedetermined by comparing the measured impedance to a known range ofimpedances value corresponding to an OTC state of the tissue. As thetissue desiccates, the impedance of the tissue changes. Therefore, theactive feedback circuitry can be provided to continuously monitor theimpedance and to indicate to the surgeon to open or close the jawsaccordingly (with appropriate indicators at the control handle, e.g.,↑=open or ←=close) so that the OTC state is maintained up to andincluding the time that sealing and cutting is performed. But, with theservo-controlled jaw movement assembly shown in FIGS. 61 to 64, the jawmovement circuitry 6142 can be programmed to open or close the jaws withspeed, precision, and accuracy.

The OTC feedback device performs particularly well when coupled to amechanism for closing and opening the jaws. Passing an upper OTC valuein a positive direction means that too much pressure is being impartedon the tissue and the motorized jaws are opened to an extent that bringsthe measured value back within the OTC range. In contrast, passing thelower OTC value in a negative direction means that too little pressureis being imparted on the tissue and the motorized jaws are closed to anextent that brings the measured value back within the OTC range. Thisself-adjusting compression device keeps compression force on theinterposed tissue within the OTC compression range during and afterdesiccation. When in the OTC range after desiccation, the devicenotifies the surgeon of this fact, referred to as a “procedure-readystate.” With this information, a delay can be pre-programmed in thedevice so that the sealing does not occur until after a time periodexpires, for example, any amount of time up to 5 seconds. In oneexemplary embodiment, if the actuation device is pressed again, then theprocedure is aborted and the surgeon can reposition the jaws or entirelyabort the operation. If the surgeon does nothing during the delayperiod, then the device automatically starts the sealing procedure.Indicating information for the procedure-ready state can be conveyed tothe surgeon audibly (e.g., with a speaker), visually (e.g., with anLED), or tactilely (e.g., with a vibration device).

Immediately after the tissue is sealed, embodiments of the deviceautomatically start the cutting procedure by powering the blade from itsretracted position to its extended position. Without any furtheractivation or movement by the surgeon, the blade is, then, returned toits retracted position to complete the sealing/cutting procedure. In anexemplary embodiment, the retraction can be activated by appropriatelypositioned limit switches that are disposed in the blade-movement areato be contacted at the appropriate time. Alternatively, the stroke ofthe powered extension/retraction device can be limited to go no furtherthan desired limits. Endpoint switches can be coupled with a mechanicalgearbox but use of the servo provides advantages because the servo canpulse modulate the speed and the distance of travel. Powered retractioninsures both that the blade does not remain in the cut tissue and thatthe blade is fully retracted. If desired, a motorized assembly can beincluded to unlock the main lever after blade retraction, allowing themain lever to spring back to its original open position (for example,through the force of a bias device, such a spring).

Closing of the jaws and movement of the blade is, in an exemplaryembodiment, carried out utilizing one or more servos. One embodimentdescribed above included a partial servo assembly where the jaws arecontrolled by hand and the knife is controlled by servo. However,another exemplary partial servo embodiment can provide an assembly wherethe jaws are controlled by the servo and the knife is controlledmanually. Both movements are executed by moving an object, such as a rodor a beam, along the longitudinal axis of the device. By appropriateplacement of one or more servos, these objects are connected directly todistal end of the servo arm (or via an intermediate linkage system).Thus, actuation of the respective servo moves the control rodlongitudinally along the axis of the device. The range of the jaw-servocan be between the fully closed and fully opened orientation of thejaws. The jaw-servo can control the jaws whether the device is asingle-moving jaw assembly or a dual-moving jaw assembly. If desired,two jaw-servos can independently operate the dual-moving jaw assembly.Either way, by controlling the jaw(s) with a servo, exact control of thejaws is made possible and, with a connection to an OTC feedback device,can permit exact and rapid jaw position control dependent upon measuredvalues, e.g., voltage, current, tissue compression, tissue impedance, toname a few. Another beneficial advantage of servo-controlled jawmovement is that the servo can vary the jaw compressing force throughoutthe cutting procedure to further insure that the OTC range ismaintained.

An advantageous feature that is provided by regulating the cutting bladewith a servo is that the designer or even the surgeon can exactlyregulate the speed of the cut. So, for example, if the surgeon knowsthat it would be beneficial for the speed of the cut to increase for aparticularly tough compressed tissue, then the surgeon could turn anon-illustrated dial (for instance) that would effect a blade speedchange.

The power-assisted actuation assembly of the present invention reducesthe number of steps to carry out the surgical cautery/cutting procedure.With the jaws of the inventive device in the normally open position, thesurgeon closes the jaws by actuating the jaw-closing trigger 5410, 6110.Like the prior art, this lever 5410, 6110 can have the pull-to-lock andpull-again-to-unlock actuation assembly. With this first pulling motion,the jaws close and impart a first intermediate sealing force to thetissue or vessel. This force need not be the final compressive force butmerely can be an intermediate stage that securely holds the tissuetherebetween. Thereafter, in a second step, the surgeon merely presses asingle button on the device and the entire procedure is carried outautomatically—the procedure including, for example, a determination ofOptimal Tissue Compression (OTC), an electrocautery process to causesealing of the tissue, a cutting movement through the sealed tissue, anda release of the jaws back to the intermediate stage. The process isfinalized in the third step by a second pulling motion on the main leverto open the jaws fully. It is noted that, in another exemplaryembodiment of the invention, the electronic control assembly can beconfigured to automatically actuate the main lever and, thereby, openthe jaws for release of the sealed/cut tissue, making it ready for thenext sealing/cutting procedure. With the invention, therefore, thesurgeon can effect a sealing and cutting procedure with only two orthree steps, these steps not requiring the surgeon to provide anysignificant external force (such as physically moving a trigger) otherthan initiating the first closure of the main lever.

As set forth in the preceding paragraph, the device of the instantinvention is able to automatically compress the tissue at a pre-definedforce that allows beneficial healing without irretrievably harming thecompressed tissue. It is known that, when tissue is being compressed(whether a single layer or multiple layers) and before cutting thetissue, it is desirable for the tissue to be at a certain compressivestate (OTC) so that a desirous medical change can occur; at the sametime, the tissue should not be compressed too far to cause tissuenecrosis. Because there is no way to precisely control the exact kind oftissue that is being placed within the compressing jaws, it is notpossible to ensure manually that the tissue is compressed within anOptimal Tissue Compression range, referred to as an OTC range.Therefore, ruling out of tissue necrosis is difficult or not possiblefor prior art electrocautery devices.

As stated above with respect to FIG. 34, at least one power cell 3520(e.g., a set of 2 to 6 lithium polymer cells having a high dischargecurrent capacity on the order of 10 to 15 times the rated storagecapacity (known as 10-15 C) is electrically connected to voltage controlcircuitry 3530, which can be, for example, a buck power supplycontrolling the output signal voltage. Radio-frequency signal generatingcircuitry 3540 receives the output signal and converts it into ahigh-frequency alternating-current signal, which AC signal is suppliedto the end effector jaws through the conductive supply ports 3512 andthe distribution panel 3410.

FIGS. 68 to 71 illustrate an exemplary embodiment of radio-frequencysignal generating circuitry 3540 with a four-layer board. FIG. 68 is thefirst layer of this four-layer circuit board. The first layer includesan oscillator 6805, a logic chip 6810, two MOSFETs 6815, 6820, and twoMOSFET drivers 6825, 6830. The oscillator 6805 establishes thefrequency. The logic chip 6810 creates a logic level signal to controlthe two MOSFET drivers 6825, 6830. Gates for the two MOSFETs 6815, 6820are connected to each respective driver 6825, 6830. A control signalconnects an inverting input of one MOSFET driver and a non-invertinginput of the second MOSFET driver. The first layer also includes a 5Vinput 6840 that drives a light emitting diode (LED) 6845.

FIG. 69 is a second layer of an exemplary embodiment of the four-layercircuit board. The second layer provides the 5V voltage (Vcc plane) toother layers of the board. The second layer provides voltage to thelogic chip and the oscillator.

FIG. 70 is a third layer of an exemplary embodiment of the four-layercircuit board. The third layer is the ground plane of the circuit board.

FIG. 71 is a fourth layer of an exemplary embodiment of the four-layercircuit board. The fourth layer includes a programmable microcontroller7105. The fourth layer also includes a 5V regulator 7110, which providesthe Vcc voltage to the second layer. Buttons and other inputs can beconnected to the available inputs on the programmable microcontroller7105.

FIG. 72 is a circuit diagram of an exemplary embodiment of a radiofrequency (RF) generator, e.g., radio-frequency signal generatingcircuitry 3540, for a vessel sealer device. This circuit is used toreceive DC input and provide AC output. The RF vessel sealer board hascapacitors C1, C2, C3, C4, C5, a resistor POT1, two MOSFETs MOSFET1,MOSFET2, a voltage regulator VLDO1, a pulse width modulation controllerU1, and a transformer T1. Direct current (DC) voltage is applied from abattery (e.g., 1880, 3500, 3600, 3880) to battery leads Battery+,Battery−. An interlock terminal controls power to the circuit throughthe voltage regulator. The main voltage (+15V) is applied to the centertap of the transformer.

The interlock is an input on the voltage regulator. The voltage appliedto the interlock is 15V, e.g. full battery voltage. The output of thevoltage regulator supplies DC voltage of about +8V to the oscillator andMOSFET driver.

Self-oscillating MOSFET driver U1 is implemented as a dual MOSFETdriver. Output A of U1 drives MOSFET1 and Output B of U1 drives MOSFET2.U1 has its own oscillator. Therefore, U1 is able to establish its ownfrequency. Using the local oscillator, U1 can switch MOSFET1 and MOSFET2on and off at the frequency generated by the oscillator.

C3 and POT1 are used to set the frequency of the oscillator. POT1 isconnected to a resistance for time delay (RTD) port of the dual MOSFETdriver U1. C3 is connected to an oscillator timing capacitor port, CT,of U1. In one exemplary embodiment, this frequency is set at about 300kHz. The frequency is set at this level because it is a minimumfrequency allowed by the Food and Drug Administration (FDA) forelectro-surgery devices.

When the output for each respective MOSFET goes high, there is a delayto charge the MOSFET gate up because the input gate of MOSFET is,substantially, a capacitor. MOSFETs get hot during the time when theyare switching from on to off. The goal is to switch the MOSFET on/offquickly. This is another reason why the lowest authorized frequency,i.e., 300 kHz, is selected for the oscillator of the dual MOSFET driver.

Only one MOSFET is active at a time. MOSFET1 grounds the top oftransformer T1 and MOSFET2 grounds the bottom of transformer T1. Theresulting output on the secondary, e.g., high voltage, side of thetransformer T1 is an approximately 120V output, which is the product ofthe turns ratio of the transformer T1 and the output voltage of thevoltage regulator. In one exemplary embodiment, the frequency of thevoltage on the secondary side of the transformer T1 is approximately 300kHz.

The capacitors C1, C2, C3, C4 serve various functions. C1 is optionaland is placed between the transformer T1 and the output R/B. C1 is notrequired for the circuit but is placed therein to comply with FDArequirements, which require a capacitor in legacy devices (which hadseparate, plug in power supplies) in order to minimize low frequencyleakage, i.e., to prevent 60 Hz current from going into the patient. Inone exemplary embodiment, the value of C1 is 0.047 uF. C2 is a filtercapacitor placed between voltage Vdd and ground. C2 is a bypasscapacitor for controlling noise. In one exemplary embodiment, the valueof C2 is 0.01 uF. As stated above, C3 is used to set the frequency ofthe oscillator in the dual MOSFET driver U1. In one exemplaryembodiment, the value of C3 is 820 pF. C4 is used as an input filter onthe battery and keeps noise from flowing upstream to the battery. In oneexemplary embodiment, the value of C4 is 47 uF. C5 is used as an outputfilter on the voltage regulator. In one exemplary embodiment, the valueof C5 is 68 uF.

FIGS. 73 and 74 illustrate a two-layer solution for a self-containedvessel sealer board implementing the circuit described with respect toFIG. 72. FIG. 73 is a first layer of an exemplary embodiment of thistwo-layer circuit board. The first layer of the RF vessel sealer boardhas capacitors C1, C2, C3, C4, C5, a resistor POT1, two MOSFETs MOSFET1,MOSFET2, a voltage regulator VLDO1, a pulse width modulation controllerU1, and a transformer T1. The aforementioned elements operate asdescribed above with respect to FIG. 72. Also included are resistors R1,R2, R3 and a capacitor C10 that are used for an optional microcontrollerto provide overall control in some applications. FIG. 74 is a secondlayer of the exemplary embodiment of the two-layer circuit board. Thesecond layer provides a position for C2, additional ground plane area,and some interconnections of the circuit.

The push-pull outlet with center tap provided by the two MOSFETS and thetransformer is able to produce an output waveform with a full duty cycleoutput, i.e., a duty cycle 50% on and 50% off for each polarity,resulting in a low crest factor. Prior art devices are regulated by apulse width modulator on the output, not a push-pull outlet. Devicesusing pulse width modulator regulation have a high crest factor, i.e.,the peak output voltage is much greater than the average output voltage.This high crest factor results in more sparking and charring and, moreimportantly, less sealing with the instrument. Using the transformer T1and the MOSFETs MOSFET1, MOSFET2 of the exemplary embodiments provides amuch better seal without the problems inherent in the prior art devices.In addition, the circuit of the present invention is configured to bethe smallest, simplest, and cheapest power supply for a Radio-Frequencygenerator. Thus, the circuit can be disposable if desired.

FIG. 75 is a process flow diagram illustrating steps for operating anexemplary embodiment of a method for providing RF tissue sealing usingthe radio-frequency signal generating circuitry 3540. The process ofmethod 7500 is used to control a switch mode power supply to providepower to a radio-frequency generator circuit in order to provideeffective and improved vessel sealing. At block 7502, a user of the RFcautery and cutting device presses a button to apply RF energy acrossdesiccating tissue (e.g., tissue clamped between the jaws of the vesselsealing end effector). At block 7504, radio-frequency generation occursfor time T₁. Tissue impedance is calculated over time T₁ at block 7506until the tissue impedance reaches a certain point at block 7508. Atblock 7510, a determination is made as to whether the tissue impedanceis greater than an intermediate value. If the tissue impedance is notgreater than this intermediate value, the RF energy is set to a lowvalue at block 7512. At block 7514, a long pause is introduced. At block7516, the cycle count is incremented by incrementing the duty cycle ofthe input voltage. At block 7518, a determination is made as to whetherthe cycle count has been incremented to be greater than or equal to acycle maximum. If the cycle maximum has been reached, the user isalerted that a fault has been detected at block 7520 and the processends at block 7522. A fault is evidence of a bad seal. If the cyclemaximum has not been reached, the process returns to block 7504.

If the tissue impedance is greater than the intermediate value, at block7524, a determination is made as to whether a tissue impedance isgreater than a high value. If the tissue impedance is greater than ahigh value, the sealing process ends at block 7526. High tissueimpedance is evidence of a good seal.

If the tissue impedance is less than this high value, the cycle count isincremented at block 7528. Tissue impedance is calculated at block 7530.At block 7532, RF energy is set to a full value. At block 7534, a shortpause is introduced. At block 7536, the RF energy is turned off. Atblock 7538, a long pause is introduced. After block 7538, the processreturns to block 7524 to determine whether the tissue impedance isgreater than a high value.

The foregoing description and accompanying drawings illustrate theprinciples, preferred embodiments and modes of operation of theinvention. More specifically, the encrypted identification systems andmethods according to the present invention have been described withrespect to an inventory system and process. However, the inventionshould not be construed as being limited to the particular embodimentsdiscussed above. Additional variations of the embodiments discussedabove will be appreciated by those skilled in the art as well as forapplications, unrelated to inventory, that require encryptedidentification of parts.

The above-described embodiments should be regarded as illustrativerather than restrictive. Accordingly, it should be appreciated thatvariations to those embodiments can be made by those skilled in the artwithout departing from the scope of the invention as defined by thefollowing claims.

We claim:
 1. An electrosurgical system for sealing and cutting tissue,comprising: a housing; an outer shaft extending distally from thehousing; an end effector extending distally from the outer shaft, theend effector including a clevis and a pair of opposing jaws pivotablyconnected to the clevis, at least one of the jaws movable relative tothe other from an open position to a closed position, each jaw includingan electrically-conductive opposing tissue-contacting inner jaw face; acutting blade disposed within the end effector and configured to movebetween a retracted position and an extended position, wherein, in theextended position, the cutting blade extends at least partially betweenthe jaws; a first motor operably coupled to the at least one jaw andconfigured to provide a first rotational output to move the at least onejaw relative to the other from the open position to the closed position;a second motor operably coupled to the cutting blade and configured toprovide a second rotational output to drive the cutting blade from theretracted position to the extended position; and electronics configuredto determine when the cutting blade is permitted to be moved safely tothe extended position based on position feedback from the first motorindicating that the at least one jaw is disposed in the closed position,the electronics configured to enable the second motor to be activated tomove the cutting blade from the retracted position to the extendedposition when a sensor determines that the cutting blade is permitted tobe safely moved to the extended position.
 2. The electrosurgical systemaccording to claim 1, wherein the end effector is configured toarticulate relative to a longitudinal axis defined through the outershaft between an aligned position and an articulated position.
 3. Theelectrosurgical system according to claim 2, wherein the end effector isconfigured to articulate relative to the longitudinal axis about atleast one articulation joint portion.
 4. The electrosurgical systemaccording to claim 3, wherein the at least one articulation jointportion includes a distal articulation joint portion coupled to theclevis of the end effector.
 5. The electrosurgical system according toclaim 1, wherein each of the jaws defines a blade trough extendingthrough the inner jaw face thereof, the cutting blade configured toextend through the blade troughs in the extended position thereof. 6.The electrosurgical system according to claim 1, wherein the first motoris a servo motor.
 7. The electrosurgical system according to claim 1,wherein the second motor is a servo motor.
 8. The electrosurgical systemaccording to claim 1, wherein the electronics are further configured toenable the supply of electrosurgical energy to the jaws when it isdetermined, based on position feedback from the first motor, that the atleast one jaw is disposed in the closed position.
 9. The electrosurgicalsystem according to claim 1, wherein the electronics are furtherconfigured to reverse the second motor to move the cutting blade fromthe extended position back to the retracted position when the cuttingblade reaches the extended position as determined based on positionfeedback from the second motor.
 10. The electrosurgical system accordingto claim 9, wherein the electronics are further configured to enablemovement of the jaws from the closed position back to the open positiononce the cutting blade is returned to the retracted position asdetermined based on position feedback from the second motor.
 11. Theelectrosurgical system according to claim 1, wherein at least a portionof the electronics is disposed within the housing.